Actavis (ACT) and Hungary-based partner Gedeon Richter announced encouraging data from a phase III study on their atypical antipsychotic drug, cariprazine. The study evaluated the efficacy and safety of cariprazine in the prevention of relapse in adults suffering from schizophrenia.
The multi-national, multi-center, randomized, double-blind, placebo-controlled 97-week study compared the use of cariprazine with placebo. Data from the study revealed that the relapse rate was 24.8% in the cariprazine arm as compared to 47.5% in the placebo arm. It was found that treatment with cariprazine was associated with a 55% reduction in the risk of relapse versus placebo in schizophrenia patients.
Apart from schizophrenia, cariprazine is also being assessed for the treatment of bipolar depression and as an adjunctive treatment for major depressive disorder in adults.
Earlier this month, Actavis and Gedeon Richter announced that the FDA has acknowledged the receipt of Actavis' new drug application (NDA) resubmission for cariprazine. The companies are looking to get cariprazine approved for schizophrenia and manic or mixed episodes associated with bipolar I disorder. A response from the FDA is expected by the second quarter of 2015.
Our Take
We are pleased with the impressive long-term efficacy data demonstrated by cariprazine in the phase III study. We expect investors to react positively to the news. As per Actavis’ press release, schizophrenia affects more than 2 million people in the U.S.
Currently approved schizophrenia treatments include AstraZeneca’s (AZN) Seroquel XR among others.
Actavis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. (AMAG) and Impax Laboratories Inc. (IPXL). While Impax Labs carries a Zacks Rank #1 (Strong Buy), AMAG holds a Zacks Rank #2 (Buy).
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