Forest Laboratories, Inc. (NYSE:FRX) and Gedeon Richter Plc.
today announced positive topline results from a Phase IIb trial
evaluating the efficacy and safety of the investigational
antipsychotic cariprazine in patients with bipolar depression.
The trial consisted of four treatment groups: cariprazine 0.75
mg/day, 1.5 mg/day, 3.0 mg/day, and placebo. Statistically
significant improvements were observed in the cariprazine 1.5
mg/day group relative to placebo at 6 weeks for the primary
endpoint, the Montgomery-Asberg Depression Rating Scale (MADRS)
total score and the key secondary endpoint, the Clinical Global
Impressions – Severity (CGI-S) score.
“We are pleased with the positive results of this study. In
addition to previously completed Phase III trials in schizophrenia
and bipolar mania, we now have positive Phase IIb studies for
cariprazine in both bipolar depression and major depressive
disorder. Our goal is to continue developing cariprazine for
patients with a broad range of psychiatric conditions,” said Marco
Taglietti, M.D., Executive Vice President of Drug Development and
Research at Forest Laboratories, Inc.
“Cariprazine is a critical element to Richter’s discovery
platform,” explained Dr. Zsolt Szombathelyi, Research Director of
Gedeon Richter Plc. “We are pleased with the topline results of the
Phase IIb trial and are committed to developing an important new
treatment option for patients suffering from bipolar
depression.”
About this Phase IIb Study
This international, randomized, placebo-controlled, fixed-dose,
8-week Phase IIb trial evaluated the efficacy and safety of
cariprazine in the treatment of patients with depressive episodes
of bipolar I disorder. Eligible patients included those with
bipolar depression who met the Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
criteria for bipolar I disorder with a current major depressive
episode. Patients also had to have a minimum score of 20 on the
17-item Hamilton Depression Rating Scale (HAM-D), a minimum score
of 2 on item 1 of the HAM-D, a minimum score of 4 on the CGI-S, and
a maximum score of 10 on the Young Mania Rating Scale (YMRS) at
both visit 1 and visit 2.
The study consisted of up to 14 days of screening followed by 8
weeks of double-blind treatment, followed by a 1-week safety
follow-up period. During the double-blind treatment period, 584
patients 18 – 65 years of age were randomized to one of four
treatment groups: cariprazine 0.75 mg/day, 1.5 mg/day, 3.0 mg/day,
or placebo. The primary endpoint was change from baseline in the
MADRS total score versus placebo at 6 weeks, using a mixed-effects
model for repeated measures (MMRM) analysis. The group who received
cariprazine 1.5 mg/day demonstrated statistically significant
improvement in the MADRS total score versus placebo at week 6
(cariprazine 0.75 mg/day: -1.9, p=0.1292; cariprazine 1.5 mg/day:
-4.0, p=0.0030; cariprazine 3.0 mg/day: -2.5, p=0.1122).
The key secondary endpoint was change from baseline in CGI-S
total score versus placebo at 6 weeks, using an MMRM analysis. The
group who received cariprazine 1.5 mg/day demonstrated
statistically significant improvement in the CGI-S score versus
placebo (cariprazine 0.75 mg/day: -0.1, p=0.3025; cariprazine 1.5
mg/day: -0.4, p=0.0132; cariprazine 3.0 mg/day: -0.3,
p=0.1122).
Across all cariprazine doses, the most common adverse events
(incidence ≥10% and greater than placebo) were akathisia and
insomnia.
About Cariprazine
Cariprazine, an investigational drug, is an orally active,
potent dopamine D3-preferring D3/D2 receptor partial agonist
atypical antipsychotic. It has a low affinity at other receptor
sites such as 5-HT2C, muscarinic, and adrenergic receptor sites.
Cariprazine is protected by a composition-of-matter patent that
expires in 2027 without patent term extension.
Cariprazine is being developed for the treatment of
schizophrenia and bipolar mania in adults. On November 21, 2013 the
companies announced that the U.S. Food and Drug Administration
issued a complete response letter regarding the new drug
application for schizophrenia and bipolar mania. In addition,
cariprazine is being investigated for the treatment of bipolar
depression and as adjunctive treatment for major depressive
disorder in adults.
About Bipolar I Disorder
Bipolar disorder, which encompasses bipolar I and bipolar II
disorders, affects approximately 5.7 million people in the U.S.
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. Patients experience
"mood episodes" that 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. Depression
that occurs in patients with bipolar disorder is called “bipolar
depression.”
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 1.2 billion (USD 1.6 billion) while its
market capitalization amounted to EUR 2.8 billion
(USD 3.8 billion) in 2013. 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) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. The Company markets a portfolio of branded drug
products and develops new medicines to treat patients suffering
from diseases principally in the following therapeutic areas:
central nervous system, cardiovascular, gastrointestinal,
respiratory, anti-infective, and cystic fibrosis. Our strategy of
acquiring product rights for development and commercialization
through licensing, collaborative partnerships, and targeted mergers
and acquisitions allows us to take advantage of attractive
late-stage development and commercial opportunities, thereby
managing the risks inherent in drug development. 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. Forest assumes no obligation
to update forward-looking statements contained in this release to
reflect new information or future events or developments.
Forest Laboratories, Inc.Frank J. Murdolo, 212-224-6714Vice
President - Investor Relationsmedia.relations@frx.comorAmanda
KaufmanMedia Relationsamanda.kaufman@frx.com
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