Forest Laboratories Inc and Gedeon Richter plc report early results from Phase II study of cariprazine for bipolar depression.
M2 EQUITYBITES-30 August 2010-Forest Laboratories Inc and Gedeon Richter plc report early results from Phase II study of cariprazine for bipolar depression(C)2010 M2 COMMUNICATIONS http://www.m2.com
Forest Laboratories Inc (NYSE:FRX) and Gedeon Richter plc reported on Monday the preliminary top-line results from an eight-week Phase II clinical trial of cariprazine for the treatment of bipolar depression.
Cariprazine is a novel, investigational antipsychotic agent which is currently also undergoing Phase III trials for separate indications of schizophrenia and bipolar mania.
In the Phase II trial for bipolar depression the overall difference observed between the drug-treated and placebo-treated groups was not statistically significant, although over the course of the trial there was evidence of a clinically relevant treatment effect in the high-dose arm of the study by comparison to placebo, the companies said.
Approximately 9% of patients discontinued the study early due to adverse events in the high dose study arm compared to 3% in the placebo arm. The companies are considering conducting an additional Phase II dose-response trial that examines a wider range of doses.
The tolerability results for cariprazine are said to support further investigation in this patient population.
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|Publication:||M2 EquityBites (EQB)|
|Article Type:||Clinical report|
|Date:||Aug 30, 2010|
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