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 as adjunctive treatment in adult patients
with Major Depressive Disorder (MDD) who have demonstrated an
inadequate response to antidepressant therapy (ADT).
The trial consisted of three treatment groups, cariprazine 1.0 –
2.0 mg/day + ADT and cariprazine 2.0 – 4.5 mg/day + ADT, and
placebo + ADT. The group who received cariprazine 2.0 – 4.5 mg/day
+ ADT demonstrated statistically significant improvement in the
Montgomery-Asberg Depression Rating Scale (MADRS) total score
versus placebo at 8 weeks, the primary endpoint.
“Forest is committed to addressing the therapeutic needs of
people living with MDD as part of our growing mental health
portfolio, and we are excited at the prospect to one day offer a
new treatment option for appropriate patients seeking an
alternative treatment to manage the condition,” said Marco
Taglietti, M.D., Chief Medical Officer and EVP, Drug Development
and Research at Forest Laboratories, Inc.
“We are encouraged by the positive top-line results shown in
this Phase IIb study,” said Dr. Zsolt Szombathelyi, Research
Director of Gedeon Richter Plc. “We are committed to continuing the
development of cariprazine in CNS disorders.”
About this Phase IIb Study
This international, multicenter, randomized, double-blind,
placebo-controlled, parallel-group, flexible-dose, 8-week Phase IIb
study evaluated the efficacy, safety, and tolerability of
cariprazine as adjunctive treatment in adult patients with MDD who
demonstrated an inadequate response to ADT. Eligible patients were
those who met Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for
MDD, had a minimum score of 22 on the MADRS scale, and had an
ongoing inadequate response to ADT.
Following a 7-14 day screening and washout period, a total of
819 patients between 18 and 65 years of age were randomized to one
of three treatment groups (either cariprazine 1.0 – 2.0 mg/day +
ADT, cariprazine 2.0 – 4.5 mg/day + ADT, or placebo + ADT) followed
by a 1-week safety follow-up period. The primary endpoint was
defined as change from baseline to end of week 8 in the MADRS total
score. Statistically significant improvement in the MADRS total
score was observed in the cariprazine 2.0 – 4.5 mg/day + ADT group
relative to the placebo + ADT treatment group (cariprazine 2.0 –
4.5 mg/day + ADT: -2.2, p=0.0114 and cariprazine 1.0 – 2.0 mg/day +
ADT: -0.9, p=0.2404) by MMRM analysis.
Across both cariprazine dose groups the most common adverse
events (incidence ≥10% and greater than placebo) were akathisia,
nausea, insomnia, somnolence, and fatigue.
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, there
are ongoing investigational clinical trials for the treatment of
bipolar depression and as adjunctive treatment of major depressive
disorder in adults.
About Major Depressive Disorder
MDD is a serious medical condition often requiring treatment,
affecting almost 16 million adults in the United States yearly or
approximately 7.3% of the adult U.S. population. MDD, also known as
depression, is a common debilitating disorder in which feelings of
sadness and other symptoms occur nearly every day for at least two
weeks and interfere with a person’s ability to work, sleep, study,
eat, and enjoy once-pleasurable activities. Among all medical
illnesses, MDD is a leading cause of disability in the U.S. The
World Health Organization predicts depression will become the
second leading cause of disability by the year 2020.
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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