Forest Laboratories, Inc. & Gedeon Richter Plc. Announce Results from Two Positive Phase III Trials with the Investigational ...
February 28 2012 - 2:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc.
today announced positive top-line results in 2 Phase III clinical
trials of cariprazine (RGH-188) for the treatment of acute
exacerbation of schizophrenia.
For the primary endpoint in each study, the Positive And
Negative Syndrome Scale (PANSS), the data showed that
cariprazine-treated patients experienced significant symptom
improvement compared to placebo-treated patients. All doses showed
statistically significant separation from placebo starting at week
2 and at each subsequent time point with the higher dose showing
separation as early as week 1 of treatment. Further analyses of the
data in each study will be completed in the coming weeks. The
results of these 2 studies were consistent with the results of the
previously completed placebo-controlled Phase IIb fixed-dose study
in this population.
Cariprazine is also currently being investigated in clinical
studies for patients with bipolar depression, and as an adjunct
treatment for Major Depressive Disorder (MDD). Recently, results
were disclosed for a third positive trial in bipolar mania.
“By successfully meeting the primary endpoint in each of these
studies, we now have 3 positive schizophrenia trials and 3 positive
bipolar mania trials,” said Dr. Marco Taglietti, President of
Forest Research Institute. “We look forward to filing the NDA for
both indications in 2012.”
“We are pleased with these results which demonstrate that
cariprazine provided significant improvement in symptoms for
patients suffering from schizophrenia,” said Dr. Zsolt
Szombathelyi, Research Director of Gedeon Richter Plc. “It is
indeed very encouraging that following successful Phase III trials
in bipolar mania and positive Phase III trials in schizophrenia, we
may offer promising treatment options for both conditions.”
About the Fixed-Dose Study
This Phase III, multinational, multicenter, double-blind,
placebo controlled, parallel-group study evaluated the efficacy and
safety of cariprazine in patients with acute exacerbation of
schizophrenia. Eligible patients were those that met the Diagnostic
and Statistical Manual of Mental Disorders, Fourth Edition, Text
Revision (DSM-IV-TR) criteria for schizophrenia and had a PANSS
total score between 80 and 120 at screening and baseline.
Following a washout period of no antipsychotic therapy for up to
7 days, a total of 617 patients between 18 and 60 years old were
randomized to one of the following treatment arms: 3 mg/d
cariprazine, 6 mg/d cariprazine, 10 mg/d aripiprazole or placebo
given once daily for 6 weeks followed by an additional 2-week
safety follow-up period, where no drug was administered. Patients
were hospitalized during the washout period and for the first 4
weeks of the double-blind treatment. Thereafter, patients were
followed either as inpatients or outpatients, as determined by the
site investigator and based on patient status.
The protocol-specified primary endpoint was the change from
baseline to Week 6 in the PANSS total score for the individual
cariprazine treatment groups compared to placebo treatment using a
mixed-effects model for repeated measures (MMRM) analysis. The
PANSS is a well accepted scale used to evaluate symptom severity in
schizophrenia. Statistically significant improvement in PANSS total
score was observed in each of the cariprazine dose groups relative
to the placebo treatment group (3 mg/day: -6.0, p=0.0044 and 6
mg/day: -8.8, p
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