Forest Laboratories Submits New Drug Application for Cariprazine for the Treatment of Both Schizophrenia & Manic or Mixed Epi...
November 28 2012 - 2:00AM
Business Wire
Forest Laboratories, Inc., (NYSE: FRX) and Gedeon Richter Plc.
announced that Forest has submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for cariprazine, a
potent dopamine D3/D2 receptor partial agonist with preferential
binding to D3 receptors. Cariprazine was discovered by Gedeon
Richter Plc and is licensed to Forest Laboratories Inc., in the
U.S. and Canada.
The application for the treatment of schizophrenia includes
results from three positive trials in over 1700 patients, two fixed
dose studies with active controls and one fixed-flexible
placebo-controlled dose study using the change from baseline in
Positive and Negative Syndrome Scale (PANSS) total score as primary
efficacy endpoint.
The application for the acute treatment of manic or mixed
episodes associated with Bipolar I Disorder includes results from
three positive placebo-controlled trials in over 1000 patients, two
flexible dose studies and one fixed-flexible dose study using the
change from baseline in the Young Mania Rating Scale (YMRS) total
score as primary efficacy endpoint.
In the schizophrenia and bipolar mania pivotal trials,
cariprazine was generally well tolerated. The most commonly
reported adverse reactions (≥5% and twice placebo), which were
predominantly mild to moderate in severity, were akathisia,
extrapyramidal disorder, dyspepsia, restlessness, tremor, fatigue
and vomiting.
About Schizophrenia
Schizophrenia is a chronic and disabling disorder that affects
more than 2 million American adults. It imposes significant burden
on patients, their families, and society. Symptoms fall into three
broad categories: positive symptoms (hallucinations, delusions,
thought disorders, and movement disorders), negative symptoms (such
as loss of motivation and social withdrawal), and cognitive
symptoms (problems with executive functioning, focusing, and
working memory).
About Bipolar I Disorder
Bipolar I disorder, also known as manic-depressive illness, is
characterized by unusual shifts in mood, energy, activity levels,
and the ability to carry out day-to-day tasks. It affects more than
5.7 million American adults. Patients experience "mood episodes"
which manifest as either a manic episode (overexcited, extreme
irritability, racing thoughts, and difficulties with sleep) or a
depressive episode (extreme sadness, fatigue or hopelessness) or a
combination of both.
About Cariprazine
Cariprazine is an orally active and potent dopamine
D3-preferring D3/D2 receptor partial agonist. Cariprazine has a low
affinity at other receptor sites such as 5-HT2C, muscarinic, and
adrenergic which have been associated with adverse events.
About Gedeon Richter Plc.
Gedeon Richter Plc. (www.richter.hu) headquartered in
Budapest/Hungary, is a major pharmaceutical company in Central
Eastern Europe, with an expanding direct presence in Western
Europe. Richter’s consolidated sales were approximately EUR
1.1 billion (USD 1.5 billion) while its market capitalization
amounted to EUR 2.1 billion (USD 2.7 billion) in 2011. The product
portfolio of the Company covers almost all important therapeutic
areas, including gynecology, central nervous system and
cardiovascular. Having the largest R&D unit in Central Eastern
Europe, the Company’s original research activity focuses on CNS
disorders. With its widely acknowledged steroid chemistry expertise
Richter is a significant player in the female healthcare field
worldwide. Richter is also active in the scope of biosimilar
product development.
About Forest Laboratories
Forest Laboratories’ (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective and respiratory,
gastrointestinal, and pain management medicine. The Company’s
pipeline, the most robust in its history, includes product
candidates in all stages of development across a wide range of
therapeutic areas. The Company is headquartered in New York, NY. To
learn more, visit www.FRX.com.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q, and any subsequent SEC filings. Forest assumes no
obligation to update forward looking statements contained in this
release to reflect new information or future events or
developments.
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