Forest Laboratories, Inc. & Gedeon Richter Plc Announce Positive Phase III Results with the Investigational Antipsychotic Car...
February 08 2012 - 2:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc.
today announced preliminary top-line results from a Phase III
clinical trial of cariprazine (RGH-188), an investigational
antipsychotic agent, in patients with acute mania associated with
bipolar I disorder.
For the primary endpoint, the Young Mania Rating Scale (YMRS),
the data showed that cariprazine treated patients with acute manic
episodes experienced significant improvements in symptoms compared
to placebo-treated patients observed as early as day five of
treatment and at each subsequent time point studied. The results of
this study were consistent with the results observed in the two
previously completed pivotal placebo-controlled cariprazine studies
in this patient population. Further analyses of the data will be
completed in the coming weeks. Cariprazine is also currently being
investigated in clinical studies for patients with schizophrenia,
bipolar depression, and as an adjunct treatment for Major
Depressive Disorder.
“As we continue to move forward with the development of this
important compound, these positive phase III results further
demonstrate the opportunity for cariprazine as a potential new
treatment option for patients suffering from bipolar mania” said
Marco Taglietti, MD, Senior Vice President of Research and
Development and President, Forest Research Institute.
“In the three consecutive positive trials, statistically
significant results demonstrated improvement in symptoms compared
to placebo, importantly including the low dose range arm. We
consider today’s results a major milestone achieved on the long
road towards bringing such a promising product to the market,”
commented Zsolt Szombathelyi, MD, Research Director of Gedeon
Richter Plc.
About the Study
This Phase III, multicenter, double-blind, placebo-controlled,
parallel-group study evaluated the efficacy, safety, and
tolerability of cariprazine monotherapy in patients with acute
mania associated with bipolar I disorder. During the five-week
study, 497 men and women, 18-65 years of age meeting the Diagnostic
and Statistical Manual of Mental Disorders, Fourth Edition, Text
Revision (DSM-IV-TR) criteria for bipolar I disorder were
randomized into three treatment groups and received at least one
dose of either cariprazine 3-6mg/day (n=167), cariprazine 6-12
mg/day (n=169) or placebo (n=161). Following a wash-out screening
period of four to seven days, patients received treatment for up to
three weeks, which was followed by a two-week period of safety
assessments. Patients were hospitalized throughout screening and
for at least the first 14 days following initiation of
treatment.
The primary protocol-specified endpoint was change from baseline
to Week 3 on the YMRS, using the mixed-effects model of repeated
measures (MMRM) analyses. The YMRS is a comprehensive,
clinician-rated instrument used to assess the severity of mania in
bipolar patients, including such parameters as elevated mood,
increased motor activity-energy, sleep, and irritability.
Statistically significant improvement was noted in both cariprazine
dose groups (3-6mg/day: -6.1 points, p
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