Forest Laboratories, Inc. & Gedeon Richter Plc Announce Results from a Phase II Study of Cariprazine for the Treatment of Bip...
August 30 2010 - 2:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc.
today announced preliminary top-line results from an 8-week Phase
II clinical trial of the novel, investigational antipsychotic agent
cariprazine for the treatment of bipolar depression. Cariprazine is
currently undergoing Phase III trials for separate indications of
schizophrenia and bipolar mania.
A total of 233 patients were randomized to enter one of two
active (low dose or high dose) treatment arms or placebo. The
primary endpoint was the Montgomery Asberg Depression Rating Scale
(MADRS) score. The study was designed to be exploratory. Although
the overall difference observed between the drug-treated and
placebo-treated groups was not statistically significant, over the
course of the trial there was evidence of a clinically relevant
treatment effect in the high-dose arm of the study by comparison to
placebo. In addition, the tolerability results for cariprazine
support further investigation in this patient population.
Approximately 9% of patients discontinued the study early due to
adverse events in the high dose study arm compared to 3% in the
placebo arm. The companies are considering conducting an additional
Phase II dose-response trial examining a wider range of doses.
About the Study
This was a randomized double-blind, placebo-controlled,
flexible-dose group study that evaluated the efficacy, safety and
tolerability of once-daily dosed cariprazine in patients with
bipolar depression. Following a washout period of no antipsychotic
therapy for at least one week, a total of 233 patients, all from
U.S. clinical sites, between ages 18 and 65 years old were
randomized to one of three treatment arms (either 0.25 - 0.75 mg
per day of cariprazine or 1.5 - 3.0 mg per day of cariprazine) or
placebo. The primary endpoint was defined as a change from baseline
to Week 8 in the MADRS total score compared to placebo
treatment.
About
Cariprazine
Cariprazine, discovered by researchers at Gedeon Richter, is an
orally active, potent D3/D2 partial agonist that preferentially
binds to D3 receptors. In addition, cariprazine has a relatively
low potency at other receptor sites, such as 5-HT2C, histamine H1,
muscarinic and adrenergic receptor sites, which have been
associated with adverse events. Cariprazine demonstrated a
reduction in symptoms in previously reported Phase II clinical
trials for schizophrenia and bipolar mania.
About Gedeon Richter
Plc.
Gedeon Richter, (www.richter.hu) headquartered in
Budapest/Hungary, is a major pharmaceutical company in Hungary and
one of the largest in Central Eastern Europe, with consolidated
sales of approximately 1 billion € (1,3 billion USD) and 3 billion
€ (4 billion USD) market capitalization in 2009. Gedeon Richter
plays the role of a regional multinational company in Central
Eastern Europe and in the CIS and has a growing presence via its
strategic partners in the US and through its commercial
subsidiaries in key EU countries. The product portfolio of the
company covers almost all important therapeutic areas, such as
cardiovascular, central nervous system, gynecology, etc. The
company has the largest R&D unit in Central Eastern Europe.
Original research activity focuses exclusively on CNS disorders
with main clinical targets being schizophrenia, anxiety, chronic
pain and depression. With its widely acknowledged steroid chemistry
expertise the company is a significant player in the female
healthcare field worldwide.
About Forest
Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical
company with a long track record of building partnerships and
developing and marketing products that make a positive difference
in people’s lives. In addition to its well-established franchises
in therapeutic areas of the central nervous and cardiovascular
systems, Forest’s current pipeline includes product candidates in
all stages of development and across a wide range of therapeutic
areas. The Company is headquartered in New York, NY. To learn more
about Forest Laboratories, 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 Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
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