Forest Laboratories, Inc. & Gedeon Richter Plc Announce Results from a Phase II Study of Cariprazine as Adjunctive Therapy in...
February 28 2011 - 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 as adjunctive therapy in major depressive disorder.
Cariprazine is currently undergoing Phase III trials for the
separate and additional indications of schizophrenia and bipolar
mania.
In this exploratory Phase II trial, a total of 231 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. 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 treatment effect in the high-dose
arm of the study compared to placebo.
In addition, tolerability results for cariprazine support
further investigation in this patient population. Approximately 3%
of patients discontinued the study early due to adverse events in
the high-dose and 1% in the low-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 Phase II trial was a U.S. multicenter, randomized
double-blind, placebo-controlled, parallel, flexible-dose group
study that evaluated the efficacy, safety and tolerability of
once-daily cariprazine in patients with major depressive disorder
who failed to respond to at least 2 antidepressant therapies (ADT).
Following a washout period of no drug therapy for one week and 8
weeks of prospective ADTs, a total of 231 patients, between ages 18
and 65 years old, were randomized to one of three treatment arms
(either 0.1-0.3 mg per day cariprazine + ADT, 1.0-2.0 mg per day
cariprazine + ADT, or placebo + ADT). The primary endpoint was
defined as change from randomization baseline to end of Week 8 in
the MADRS total score.
About Cariprazine
Cariprazine, discovered by researchers at Gedeon Richter, is an
orally active, potent D3/D2 partial agonist that preferentially
binds to D3 receptors. Cariprazine also has a relatively low
potency at other receptor sites, such as 5-HT2C, histamine H1, and
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, (http://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 EUR (1,3 billion USD) and 3
billion EUR (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) longstanding global partnerships
and track record developing and marketing pharmaceutical products
in the United States has yielded its well-established central
nervous system and cardiovascular franchises and innovations in
anti-infective 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 Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
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