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The U.S. fda.gov/” rel=”nofollow”>Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted that Zyprexa(R) (olanzapine), an atypical antipsychotic, is effective and acceptably safe for the acute treatment of schizophrenia or manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old. The panel supported the FDA and Lilly’s position that if Zyprexa is approved for the two indications, prescribers should consider other treatment options first for adolescent patients.

“This Committee of experts spent two days discussing the science of a difficult topic being debated in media, doctors’ offices and living rooms across the country,” said John Hayes, M.D., vice president of Lilly Research Laboratories. “Today’s Committee vote is an important step toward providing help and hope to the many teens suffering from severe mental illness.”

FDA will consider the panel’s recommendations in its review of the supplemental New Drug Applications that Lilly submitted for Zyprexa. The FDA takes the advice of its Advisory Committees into consideration when deciding whether to approve new indications, but is not bound by their recommendations.

For the proposed schizophrenia indication, the panel voted 11-5, with two abstentions, that Zyprexa’s effectiveness had been demonstrated, and voted 10-4, with four abstentions, that these data demonstrated acceptable safety. For the proposed indication for manic or mixed episodes associated with bipolar I disorder, the panel voted 17-0, with one abstention, that Zyprexa’s effectiveness had been demonstrated, and voted 11-4, with three abstentions, that these data demonstrated acceptable safety.

The Committee examined findings from two pivotal clinical trials of Zyprexa in adolescents with schizophrenia or bipolar I disorder, including a six-week double-blind, placebo-controlled trial to assess the efficacy and safety of Zyprexa in 72 adolescents (aged 13-17 years old) with schizophrenia; and a three-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of Zyprexa in 107 adolescents (aged 13-17 years) with acute manic or mixed episodes associated with bipolar I disorder.

In these studies, adolescents taking Zyprexa experienced significant improvements in their schizophrenia and bipolar symptoms on various efficacy measures. Symptoms of schizophrenia include acute episodes of delusions, hallucinations and long-term impairments such as diminished emotion, lack of interest and depressive signs and symptoms(1). Manic symptoms of bipolar I disorder include long periods of euphoria, restlessness, behaving impulsively and being easily distracted(2). A mixed bipolar state occurs when symptoms of depression and mania are experienced at the same time(3).

In addition to the two placebo-controlled studies, the Committee reviewed extensive Zyprexa safety data relevant to adolescents. Increased weight, appetite, and sedation were among the most common adverse events observed in adolescents. Weight gain was greatest in adolescents who were overweight or obese when they began treatment. Significant weight gain was also observed in patients who were of normal weight at baseline.

Although no clinical trials comparing adolescents to adults were conducted, data from the adolescent trials were compared to those from the adult trials. The types of adverse events observed in adolescents treated with Zyprexa were similar to those seen in adults. The incidence and magnitude of changes in weight, prolactin, triglyceride, cholesterol and hepatic enzyme levels were greater in adolescents than adults. Sedation was also more common in adolescents than adults.

“Because weight gain and some of the metabolic changes are more likely to occur and to be more pronounced in adolescents compared to adults, we agreed with the FDA that in many cases other available treatment options should be considered before Zyprexa when treating adolescents,” said Dr. Hayes.

About Schizophrenia in Adolescents

Schizophrenia affects about 1 percent of Americans(4). A substantial portion of first psychotic breaks for schizophrenia occur in adolescence. It has been estimated that 39 percent of males and 23 percent of females with schizophrenia experience onset of the disease before the age of 19(5). Studies have suggested that early-onset schizophrenia is associated with worse long-term outcomes compared to onset of illness in adulthood(6).

About Bipolar Disorder in Adolescents

Bipolar disorder affects approximately 5.7 million American adults, or about 2.6 percent of the U.S. population age 18 and older in a given year(7). It has an estimated prevalence of 0.1 percent to 2 percent among adolescents(8). Lifetime prevalence of bipolar I disorder in community samples has varied from 0.4 percent to 1.6 percent(9). It has been estimated that 20 percent of all patients with bipolar disorder experience their first manic episode during adolescence, with the peak age of onset for this group of patients occurring between 15 and 19 years of age(10). Early onset of bipolar disorder is associated with greater severity of illness and more functional impairment(11).

Safety information for Oral Zyprexa (olanzapine)

Zyprexa is indicated in adults in the United States for the acute and maintenance treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar I disorder.

Zyprexa is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with Zyprexa.

The possibility of a suicide attempt is inherent in schizophrenia and bipolar I disorder. Close supervision of high-risk patient should accompany drug therapy.

As with all antipsychotic medications, a rare and potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) has been reported with Zyprexa. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics, including Zyprexa. While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and Zyprexa appears to have a greater association than some other atypical antipsychotics. Physicians should consider the risks and benefits when prescribing Zyprexa to patients with an established diagnosis of diabetes mellitus, or having borderline increased blood glucose level. Patients taking Zyprexa should be monitored regularly for worsening of glucose control. Patients starting treatment with Zyprexa should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, palyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.

Undesirable alterations in lipids have been observed with Zyprexa use. Clinical monitoring, including baseline and follow-up lipid evaluations in patients using Zyprexa, is advised. Clinically significant, and sometimes very high, elevations in triglyceride levels and modest mean elevations in total cholesterol have been observed with Zyprexa use.

Potential consequences of weight gain should be considered prior to starting Zyprexa. Patients receiving Zyprexa should receive regular monitoring of weight.

As with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Zyprexa may induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia, and in some patients, syncope, especially during the initial dose-titration period. Particular caution should be used in patients with known cardiovascular disease, cerebrovascular diseases, or those predisposed to hypotension.

Other potentially serious adverse events include seizures, elevated prolactin levels, cognitive and motor impairment, body temperature elevation, and trouble swallowing.

The most common treatment-emergent adverse event associated with Zyprexa use in adults in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world’s most urgent medical needs

Zyprexa(R) (olanzapine, Lilly)

This press release contains forward-looking statements about Zyprexa. These statements reflect management’s current beliefs; however, as with any pharmaceutical product there are risks and uncertainties in the process of research and development, regulatory review, and commercialization. There is no guarantee that Zyprexa will be approved for the acute treatment of schizophrenia or manic or mixed episodes associated with bipolar I disorder in adolescents, or that, if approved, it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

References

(1) The National Institute for Mental Illness. “About Mental Illness: Early Onset Schizophrenia.”

(2) The Child & Adolescent Bipolar Foundation. About Pediatric Bipolar Disorder.

(3) The National Institute of Mental Health. About Mental Illness: Bipolar Disorder.

(4) The National Institute of Mental Health. What is Schizophrenia?

(5) Loranger, AW (1984): Sex difference in age of onset of schizophrenia. Archives of General Psychiatry; 41: 157-161

(6) Fleischhaker, C. et al. Long-term Course of Adolescent Schizophrenia. Schizophrenia Bulletin 2005 31(3):769-780; doi:10.1093/schbul/sbi014.

(7) Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 2005 Jun;62(6):617-27.

(8) Mauricio Tohen et al. (2007). Olanzapine versus Placebo in the Treatment of Adolescents with Bipolar Mania. Am J Psychiatry 2007, 164: 1547-1556

(9) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, pg. 385.

(10) Korn, M. (2002). Building Foundations Toward Recovery in Bipolar Disorder. How Prevalent are Mood Disorders in Children and Adolescents?

(11) Axelson D et al. (2006). Phenomenology of children and adolescents with bipolar spectrum disorders. Archives of General Psychiatry; 63(10):1139-48.

Source: Eli Lilly and Company

View drug information on Zyprexa.

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Bipolar I disorder patients with a predominant manic/hypomanic polarity (MP) are similar in temperament to those with a predominant depressive polarity (DP), but differ from patients with unipolar major depression (UP), research shows.

Writing in the Journal of Affective Disorders, Eduard Vieta (University of Barcelona, Spain) and team explain: “Recently, the concept of predominant polarity… has been introduced to further characterize subtypes of bipolar disorders.”

They add: “This concept has been proven to have diagnostic and therapeutic implications, but little is known on the underlying psychopathology and temperaments.“

To validate the concept of predominant polarity and investigate the relationship with temperament, the team studied 124 patients with bipolar I disorder and 19 with UP.

The bipolar patients were assessed for predominant polarity, with DP defined as at least two thirds of past episodes fulfilling the DSM-IV criteria for major depressive episode, and MP defined as at least two thirds of past episodes fulfilling DSM-IV criteria for manic or hypomanic episodes.

All the participants underwent temperament assessments using the Temperament Evaluation of the Memphis, Pisa, Paris, and San Diego Auto questionnaire (TEMPS-A). Temperament was assessed when patients were in full remission according to the DSM-IV criteria (no significant signs or symptoms of the disorder during the past 2 months).

The team found that 55% of the bipolar disorder patients met criteria for predominant polarity, with 47 classified as MP and 22 as DP.

Age at onset was lower in both the MP and DP bipolar groups compared with the UP group. Unipolar patients showed a longer duration of depression compared with both the MP and DP bipolar groups, but there were no significant differences in the number of suicide attempts between the groups.

Regarding temperament assessments, the mean TEMPS-A scores on the hyperthymic and cyclothymic subscales were higher in MP and DP patients compared with UP patients, while the UP group scored significantly higher than both MP and DP bipolar groups on the depressive temperament scores.

Anxious temperament scores were statistically higher in the UP group than the MP group, but did not differ between DP and UP groups. Irritable temperament scores did not differ among the three groups.

Overall, there were no significant differences in temperament profiles between the MP and DP bipolar groups.

Vieta et al conclude: “Our results show that both bipolar I MP and DP subgroups are temperamentally similar and different from UP. Depression in DP bipolar I patients should be viewed as the overlap of depression on a hyperthymic/cyclothymic temperament.”

They add: “These findings confirm the value of the predominant polarity concept as well as the importance of temperaments to separate bipolar from unipolar disorders.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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UK researchers have found that individuals with bipolar disorder (BD) respond differently to positive mood induction than healthy individuals.

They hope that knowing how patients with bipolar disorder respond to positive mood induction could enable clinicians to help BD patients better regulate their mood. Guidance during cognitive behavioral therapy could teach patients to become aware of the automatic changes to emotional processing that occur during the early stages of mood elevation.

In the present study, Anne Farmer (Institute of Psychiatry, London) and co-authors investigated the effect of positive mood induction on emotional processing in 15 euthymic individuals with BD and 19 gender- and age-matched healthy controls, using the Affective Go/No-go test (AGNG) and the Cambridge Gamble task (CGT).

The researchers manipulated mood using a feedback paradigm, which was found to be more effective than more widely used techniques. Mood induction using the “Go” task significantly elevated mood in both groups, and this effect lasted until after completion of the AGNG and CGT.

Patients in the BD group responded more slowly on the CGT when presented with more difficult decisions (when the probability of being correct was lower) than controls, and this effect remained significant after adjusting for age. However, no differences were seen between groups in the extent to which participants altered their betting behavior as a function of risk, or in the quality of decision making.

The authors say that the slow responses made in the face of a difficult decision reflect the BD patients’ “difficulty in overcoming the inclination to engage in behavior with a high potential for negative consequences, which may have been elicited by the mood induction.”

Furthermore, bipolar patients showed a positive emotional bias on the AGNG, as they made significantly more inappropriate responses to positive distractor words than negative distractor words following mood induction, whereas controls did not.

“These data suggest that individuals with BD and healthy controls respond to positive mood induction in a qualitatively different manner,” write the authors in the journal Psychological Medicine.

Farmer et al say that positive mood induction in euthymic individuals with BD “is sufficient to re-establish the biases in information processing and disruptions to decision-making behavior that occur in the manic state.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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People with bipolar disorder in Brazil are more likely to be obese than the general population, say researchers in findings that emphasize the importance of early detection and treatment of obesity and the metabolic syndrome among such patients in developing countries.

Previous studies conducted in the USA and other developed countries have shown an “alarmingly” high prevalence of obesity and the metabolic syndrome in patients with bipolar disorder, explain Karla Mathias de Almeida and colleagues from the University of São Paulo School of Medicine in Brazil.

But they add that “little is known about the prevalence of these conditions in patients with bipolar disorder in developing countries,” which have lower overall levels of obesity compared with developed countries.

The team therefore studied the prevalence of obesity and the metabolic syndrome among 84 Brazilian outpatients, aged at least 18 years, with bipolar disorder who were participating in the Bipolar Research Program at University of São Paulo.

Patients were considered overweight if their body mass index (BMI) was 25??”29.99 kg/m² and obese if their BMI was more than 30 kg/m².

The metabolic syndrome was defined by the presence of at least three of the following: a waist circumference of >102 cm in men or >88 cm in women; elevated triglycerides (? 150 mg/dl); reduced high-density lipoprotein cholesterol (<40 mg/dl in men or <50 mg/dl in women); elevated blood pressure (systolic blood pressure ? 130 mmHg or diastolic blood pressure ? 85 mmHg); and elevated fasting glucose (? 100 mg/dl).

The researchers found that 27 (32.0%) bipolar patients were overweight and 30 (35.7%) were obese. The prevalence of obesity among the patients was significantly higher than that in the Brazilian population (8.8??”13.0%), notes the team.

Nearly one-third (28.6%) of patients also met criteria for the metabolic syndrome, which the researchers say is similar to that in the Brazilian population, (20.0??”29.8%).

“Our data suggest that the higher prevalence of obesity among patients with bipolar disorder is a cause for concern not only in developed countries but may also apply for developing countries,” de Almeida and team conclude in the journal Acta Neuropsychiatrica.

They add: “In the interest of early detection and treatment of the metabolic syndrome and obesity, psychiatrists should routinely assess metabolic parameters and weight gain in patients with bipolar disorder.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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Study results suggest that the lifetime presence of recurrent panic attacks may differentiate between subgroups of patients with mood disorders, especially in those with bipolar disorder.

To elucidate the relationship between the comorbidity of panic and affective disorders, UK researchers compared lifetime clinical illness characteristics and items of symptomatology in 290 patients with bipolar I disorder (BPI) and 335 patients with major depressive disorder (MDDR) according to the lifetime presence of recurrent panic attacks.

Nick Craddock (Cardiff University) and co-authors found that 47% and 58% of patients with BPI and MDDR, respectively, had a lifetime history of panic attacks.

A higher score on the Beck Depression Inventory was significantly associated with the lifetime presence of panic attacks in patients with BPI and MDDR (odds ratio [OR]=1.05), as did a younger age at the baseline interview in patients with BPI (OR=0.97).

Compared with patients with BPI and without a lifetime history of recurrent panic attacks, those with a history of panic attacks were significantly more likely to experience suicidal behavior, more severe impairment during the worst depressive episode (as rated using the Global Assessment Scale), and more frequent and severe depressive episodes (according to the Bipolar Affective Disorder Dimension Scale [BADDS]) with corresponding odds ratios (ORs) of 1.82, 0.97, and 1.02.

Patients with MDDR and a positive history of recurrent panic attacks were twice as likely to have had inpatient treatment at least once in their lifetime as their counterparts without a panic attack history, and scored higher on the BADDS (OR=1.03).

The researchers also looked at items of psychopathology in BPI and MDDR patients using the Operational Criteria symptom checklist. They found that patients with BPI and a history of panic attacks were approximately twice as likely to experience diurnal variation, slowed activity, and insomnia, and almost four times more likely to early-morning waking and agitated activity compared with BPI patients without panic attacks.

Furthermore, MDDR patients with a panic attack history were approximately twice as likely to experience suicidal ideation and slowed activity as MDDR patients without this history.

The authors note that no association was seen between the lifetime presence of panic attacks and clinical characteristics of illness relating to mania.

“The presence of recurrent panic attacks in bipolar and unipolar disorder may be indicative of a course of illness associated with a greater depressive morbidity,” conclude the authors in the journal Bipolar Disorders.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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Researchers have found significant elevations of choline-containing compounds in the hippocampus and orbitofrontal cortex of euthymic patients with bipolar disorder (BD), suggesting that these regions are involved in the pathophysiology of BD.

Since metabolite concentrations in the orbitofrontal cortex and hippocampus have not been extensively studied in BD patients, Canadian researchers performed proton magnetic resonance spectroscopy in 12 euthymic BD patients and 12 age- and gender-matched controls to assess levels of N-acetyl aspartate (NAA), glutamate, and glycerophosphocholine+phosphocoline (GPC+PCh).

Patients were aged 42.1 years on average and had an average illness duration of 30.0 years, mean Young Mania Rating Scale score of 2.4, and a mean Beck Depression Inventory score of 7.5. In total, 67% were being treated with lithium, 33% with atypical antipsychotic medication, 75% with anti-convulsant medications, and 33% with antidepressants.

Geoffrey Hall (McMaster University, Ontario, Canada) and co-authors found that levels of GPC+PCh were significantly increased in the hippocampus (1.97 vs 1.61 µM) and in the orbitofrontal cortex (2.07 vs 1.79 µM) compared with controls.

As choline is a marker of membrane phospholipid metabolism, elevated choline levels may indicate increased membrane turnover and active neurodegeneration characteristic of disorders such as Alzheimer’s and Huntington’s disease, say the authors.

Glutamate levels were also significantly elevated in the occipital cortex in BD patients compared with controls (16.52 vs 13.98 µM), but not in the hippocampus or orbitofrontal cortex.

Conversely, NAA levels were comparable between the groups in all three studied brain regions ??” a result consistent with previous studies, and one that may “may reflect a lithium-induced normalization of NAA in these regions,” according to Hall et al.

Writing in the journal Psychiatry Research: Neuroimaging, the researchers caution: “An obvious limitation of the study is that patients were treated with a variety of medications and these medications may influence metabolite levels.”

They suggest that future studies should include patients with variable illness burden to determine whether the findings generalize from this chronic group of patients to those earlier in the course of illness.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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Among inpatients with affective disorder, clinical improvement and antidepressant treatment is associated with a significantly reduced risk for suicide during hospitalization and after discharge, study results show.

“The risk of suicide in patients with affective disorders is particularly high immediately after admission to, and discharge from a psychiatric hospital,” explain E Høyer, from the University of Aarhus in Denmark, and team.

However, they add that among such patients, “only few risk factors for suicide have been identified” and “little is known about the protective or other effects of treatment.“

To investigate further, the researchers studied data on 282 Danish patients, aged at least 18 years, who were admitted to hospital with affective disorder between 1994 and 1995. Of these, 141 died because of suicide, either during admission or shortly after discharge.

The researchers assessed the patients’ demographic and socioeconomic factors, family history, psychiatric history, treatment, and history of adverse life events, such as bereavement of close relative or friend, separation/divorce, and loss of a job.

Clinical improvement, or no such improvement, during hospitalization was noted if such information was available in the patients’ case files. If no such information was available, the clinical state of the patient at admission and at censoring date was used to make an evaluation.

The team identified four variables that were independent predictors of suicide.

As expected, a previous history of suicide attempts was associated with the greatest risk for death by suicide (incidence-rate ratio [IRR]=4.9). The team also found that loss of a job during the year prior to the index admission was associated with a significant increased risk for suicide, at an IRR of 2.9. This was the only adverse life event associated with an increased risk for suicide, note the researchers

Conversely, clinical improvement during the index admission and treatment with antidepressant drugs were associated with a reduced risk for suicide, both at IRRs of 0.3.

Høyer and team conclude: “Our interpretation of the findings is that clinical improvement of affective disorder and treatment with antidepressant drugs may reduce the risk of suicide. Therefore, and for clinical reasons in general, all efforts should be made to enhance clinical improvement and prevent further episodes of illness.”

They add: “It is important to be aware of the risk of suicide in patients with no or little clinical improvement during inpatient treatment, especially at discharge and during leave from the hospital.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the U.S. Food and Drug Administration (FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline ’s (NYSE: GSK) Lamictal® ODT™ (lamotrigine) Orally Disintegrating Tablets. Co-developed by Eurand and GSK, Lamictal ODT uses Eurand’s AdvaTab® orally disintegrating tablet (ODT) and Microcaps® taste-masking technologies to provide Lamictal in a pleasant-tasting tablet that disintegrates on the tongue and that may be taken with or without liquid.

Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older who have been treated for mood episodes with other medicine. It is not known if Lamictal ODT is safe or effective in children or teenagers under the age of 18 with mood disorders such as bipolar disorder or depression. Lamictal ODT is also used together with other medicines to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people 2 years or older or alone when changing from other medicines used to treat partial seizures in people 16 years or older. It is not known if Lamictal ODT is safe or effective when used alone as the first treatment of seizures in adults. Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and 200 mg strengths and is expected to be available in pharmacies in early July 2009.

“We were delighted to have the opportunity to use our AdvaTab® and Microcaps® proprietary technologies to co-develop Lamictal ODT with GSK, and we look forward to a successful launch,” said Gearóid Faherty, Chairman and Chief Executive Officer. “We see Lamictal ODT, Eurand’s fifth FDA-approved drug since 2001, as another clear demonstration of the breadth of our drug formulation expertise and the depth of our pipeline.”

Eurand will receive an undisclosed milestone payment upon launch, revenue for manufacturing Lamictal ODT tablets for GSK, royalties on net sales of the product and milestone payments in connection with Lamictal ODT achieving predetermined sales levels in the U.S. marketplace.

Net sales of Lamictal®, one of the world’s top 60 pharmaceutical products based on annual sales, were $1.3 billion in the U.S. in 2008. Eurand retains exclusive worldwide manufacturing rights to Lamictal ODT and, subject to certain conditions, either Eurand or GSK may have certain rights to commercialize the product in a particular country outside the U.S.

Lamictal ODT uses a combination of two of Eurand’s novel drug delivery technologies. AdvaTab® orally disintegrating tablet technology uses Eurand’s proprietary granulation and tabletting processes that allow the tablet to disintegrate rapidly in the mouth without chewing or the need for liquid. AdvaTab is distinct from conventional ODT technologies because it can be combined with Microcaps® taste-masking technology. Microcaps® taste-masking technology provides a coating that encapsulates drug particles, forming a barrier between the medication and the taste buds while still allowing the drug to dissolve in the stomach.

Safety Information

Prescription Lamictal ODT Tablets are not for everyone. Lamictal ODT is another form of Lamictal. Lamictal may cause a serious skin rash that may cause the patient to be hospitalized or to stop Lamictal; it may rarely cause death. There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when the patient begins taking Lamictal, within the first 2 to 8 weeks of treatment. But it can happen in people who have taken Lamictal for any period of time. Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking Lamictal.

The risk of getting a rash is higher if taking Lamictal while taking valproate (Depakene® (valproic acid) or Depakote® (divalproex sodium)), taking a higher starting dose of Lamictal than a healthcare provider prescribed or increasing the dose of Lamictal faster than prescribed.

Lamictal can also cause other types of allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. The patient may or may not have a rash with these types of reactions.

The patient should call their healthcare provider right away if they have any of the following: a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, yellowing of the skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine the patient to decide if they should continue taking Lamictal.

Antiepileptic drugs, including Lamictal, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Medication errors involving Lamictal have occurred. In particular, the name Lamictal or lamotrigine can be confused with the names of other commonly used medications. Medication errors may also occur between the different formulations of Lamictal. To reduce the potential of medication errors, healthcare professionals should write and say Lamictal clearly. Depictions of the Lamictal Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets can be found in the Medication Guide that accompanies the product to highlight the distinctive markings, colors, and shapes that serve to identify the different presentations of the drug and thus may help reduce the risk of medication errors. To avoid the medication error of using the wrong drug or formulation, patients should be strongly advised to visually inspect their tablets to verify that they are Lamictal, as well as the correct formulation of Lamictal, each time they fill their prescription.

Patients should not take Lamictal or Lamictal ODT if they have had an allergic reaction to lamotrigine or to any of the inactive ingredients.

Common side effects include dizziness, headache, blurred or double vision, lack of coordination, sleepiness, nausea, vomiting, insomnia, tremor, rash, fever, abdominal pain, back pain, tiredness, and dry mouth. Patients should tell their healthcare provider about any side effect that bothers them or does not go away; patients should tell their healthcare provider if they have any changes in their menstrual pattern, such as breakthrough bleeding, while taking Lamictal and birth control pills. These are not all the possible side effects of Lamictal.

* Depakene and Depakote are registered trademarks of Abbott Laboratories

For full prescribing information including Boxed Warning, please visit http://www.lamictal.com and click on “Complete Prescribing Information for Lamictal” to view prescribing information for all formulations, including Lamictal ODT.

About AdvaTab®

Eurand’s AdvaTab® technology utilizes proprietary granulation and tabletting processes to provide an orally disintegrating tablet with superior mouth-feel attributes. When combined with Eurand’s Microcaps® taste-masking technology, AdvaTab ODTs are one of the leading orally disintegrating tablet systems available to the pharmaceutical industry today. Key features of AdvaTab® include: excellent mouth-feel; tablets that can be packaged in bottles or blisters; rapid disintegration in the oral cavity; ability to incorporate microencapsulated drug particles; and the capacity to incorporate larger drug doses than conventional ODT technologies.

About Microcaps®

Eurand’s microencapsulation technology, known as Microcaps®, employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation. This includes taste and odor masking, customized release profiles, conversion of liquids to solids and the separation of incompatible materials. Microcaps® is incorporated in more than 12 marketed products.

Source
Eurand

View drug information on Lamictal.

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Eurand N.V.
(NASDAQ: EURX), a specialty pharmaceutical company that develops
enhanced pharmaceutical and biopharmaceutical products based on its
proprietary pharmaceutical technologies, announced that the
U.S. Food and Drug Administration (FDA) has approved EUR-1048, to be
marketed as GlaxoSmithKline ’s (NYSE: GSK) Lamictal(R) ODT(TM)
(lamotrigine) Orally Disintegrating Tablets. Co-developed by Eurand
and GSK, Lamictal ODT uses Eurand’s AdvaTab(R) orally disintegrating
tablet (ODT) and Microcaps(R) taste-masking technologies to provide
Lamictal in a pleasant-tasting tablet that disintegrates on the
tongue and that may be taken with or without liquid.

Lamictal ODT is indicated for the long-term treatment of Bipolar I
Disorder to lengthen the time between mood episodes in people 18 years
or older who have been treated for mood episodes with other medicine.
It is not known if Lamictal ODT is safe or effective in children or
teenagers under the age of 18 with mood disorders such as bipolar
disorder or depression. Lamictal ODT is also used together with other
medicines to treat certain types of seizures (partial seizures,
primary generalized tonic-clonic seizures, generalized seizures of
Lennox-Gastaut syndrome) in people 2 years or older or alone when
changing from other medicines used to treat partial seizures in
people 16 years or older. It is not known if Lamictal ODT is safe or
effective when used alone as the first treatment of seizures in
adults. Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and
200 mg strengths and is expected to be available in pharmacies in
early July 2009.

“We were delighted to have the opportunity to use our AdvaTab(R) and
Microcaps(R) proprietary technologies to co-develop Lamictal ODT with
GSK, and we look forward to a successful launch,” said Gearoid
Faherty, Chairman and Chief Executive Officer. “We see Lamictal ODT,
Eurand’s fifth FDA-approved drug since 2001, as another clear
demonstration of the breadth of our drug formulation expertise and
the depth of our pipeline.”

Eurand will receive an undisclosed milestone payment upon launch,
revenue for manufacturing Lamictal ODT tablets for GSK, royalties on
net sales of the product and milestone payments in connection with
Lamictal ODT achieving predetermined sales levels in the U.S.
marketplace.

Net sales of Lamictal(R), one of the world’s top 60 pharmaceutical
products based on annual sales, were $1.3 billion in the U.S. in 2008.
Eurand retains exclusive worldwide manufacturing rights to Lamictal
ODT and, subject to certain conditions, either Eurand or GSK may have
certain rights to commercialize the product in a particular country
outside the U.S.

Lamictal ODT uses a combination of two of Eurand’s novel drug
delivery technologies. AdvaTab(R) orally disintegrating tablet
technology uses Eurand’s proprietary granulation and tabletting
processes that allow the tablet to disintegrate rapidly in the mouth
without chewing or the need for liquid. AdvaTab is distinct from
conventional ODT technologies because it can be combined with
Microcaps(R) taste-masking technology. Microcaps(R) taste-masking
technology provides a coating that encapsulates drug particles,
forming a barrier between the medication and the taste buds while
still allowing the drug to dissolve in the stomach.

Source
Eurand N.V.

View drug information on Lamictal.

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• Bipolar Disorder - Eurand Announces FDA Approval Of EUR-1048 (Lamictal(R) ODT(TM)), Co-Developed With GlaxoSmithKline