The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person’s mood, energy, and ability to function.

“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.”

The most common symptoms of schizophrenia include hearing voices, or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid. These thoughts may be terrifying and can cause fearfulness, withdrawal, agitation or violence.

Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.
Saphris is in a class of drugs called atypical antipsychotics. All atypical antipsychotics contain a boxed warning, the FDA’s strongest warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis (a brain disorder that lessens the ability to remember, think, and reason). Saphris is not approved for these patients.

The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia.

The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term placebo-controlled and active-drug controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder.

The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were the inability to sit still or remain motionless (akathisia), decreased oral sensitivity (oral hypoesthesia) and drowsiness (somnolence).

The most common adverse reactions reported by patients in clinical trials using Saphris to treat bipolar disorder were drowsiness, dizziness, movement disorders other than akathisia and weight increase.

Saphris is manufactured by Schering-Plough, Kenilworth, N.J.

Source: FDA

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved bipolar disorder.

Bipolar disorder, which affects approximately 5.7 million adults in the United States, is a debilitating, chronic condition that requires lifelong treatment and management.1 More than 90 percent of patients with bipolar disorder have recurring mood episodes,2 making it important to establish a long-term treatment plan to help prevent recurrence and stabilize mood. The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives, and the disease is associated with high rates of disability.3

“The FDA approval of Geodon provides an additional treatment option for patients with bipolar disorder, who require maintenance therapy to keep the symptoms of the disease under control,” said Charles Bowden, clinical professor of psychiatry and pharmacology, University of Texas Health Science Center.

The efficacy and safety of Geodon for the adjunctive maintenance treatment of bipolar disorder were studied in a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder. After an open-label stabilization period of 10 to 16 weeks, 240 patients were randomized to continue on Geodon plus lithium or valproate, or to have Geodon replaced by placebo.4 The primary endpoint in this study was time to recurrence of a mood episode requiring intervention.

The data demonstrated that Geodon plus lithium or valproate was superior to placebo plus lithium or valproate in increasing the time to recurrence of a mood episode. During six months of treatment, 19.7 percent of patients in the Geodon arm required intervention for a mood episode, compared with 32.4 percent of patients in the placebo arm.4

The adjunctive Geodon treatment regimen was generally well-tolerated.4 Discontinuation due to adverse events occurred in 13 percent of patients in the placebo group, compared with 9 percent of those in the Geodon group.5 The safety and tolerability data from this study are consistent with Geodon’s already well-established safety profile in adult patients.

“The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives,” said Dr. Ilise Lombardo, senior medical director, Pfizer Specialty Care. “This approval underscores Pfizer’s commitment to supporting people suffering from serious mental health disorders.”

Geodon is also FDA-approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia. Since the FDA approval of Geodon in February 2001, nearly 2 million adult patients have been treated with this important therapy.6

1 National Institute of Mental Health. Bipolar disorder. Available here. Accessed October 27, 2009.

2 Solomon DA, Keitner GI, Miller IW, Shea MT, Keller MB. Course of illness and maintenance treatments for patients with bipolar disorder. J Clin Psychiatry. 1995;56:5-13.

3 Sajatovic M. Bipolar disorder: disease burden. Am J Manag Care. 2005;11:S80-S84.

4 Vieta E, Bowden C, Ice KS, et al. A 6-month, randomized, placebo-controlled, double-blind trial of ziprasidone plus a mood stabilizer in subjects with bipolar I disorder. Poster presented at the 17th European Psychiatric Association European Congress of Psychiatry, January 25, 2009, Lisbon, Portugal.

5 Pfizer Inc. Clinical study report synopsis: Protocol A1281137. A phase 3, randomized, 6-month, double blind trial in subjects with bipolar I disorder to evaluate the continued safety and maintenance of effect of ziprasidone plus a mood stabilizer (vs placebo plus a mood stabilizer) following a minimum of 2 months of response to open-label treatment with both agents.

6 Data on file. Pfizer Inc.

Source
Pfizer Inc.

View drug information on Ziprasidone.

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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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