Forest Laboratories and Gedeon Richter Plc announced positive top-line results from a Phase 2b trial of the investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia. This placebo- and active-controlled, fixed dose trial enrolled patients who met the DSM-IV-TR criteria for schizophrenia and had a PANSS total score between 80 and 120.  The primary endpoint of the study was the change from baseline to Week 6 in the PANSS total score for the individual cariprazine fixed dose treatment groups compared to placebo treatment using a sequential multiple-comparison test procedure and last observation carried forward (LOCF) analyses. The secondary endpoint was the change from baseline to Week 6 in the Clinical Global Impression-Severity Score (CGI-S), a scale used to assess treatment response.

Statistically significant (p<0.001) improvement in the PANSS total score at the end of Week 6 was observed for the comparison of each cariprazine dose group relative to the placebo treatment group (change of -7.5, -8.9, and -10.4 points for the 1.5mg/day, 3mg/day, and 4.5mg/day dose groups, respectively) by LOCF analyses. Statistically significant improvements were also noted in each cariprazine dose group relative to placebo treatment in the CGI-S by LOCF analysis. Statistically significant improvements were also seen in the comparator risperidone group relative to placebo treatment in the total PANSS and CGI-S measures by LOCF analysis.

Cariprazine is an orally active D3/D2 partial agonist with preferential binding to D3 receptors. Additionally, cariprazine has a relatively low potency at other receptor sites, such as 5-HT2C, histamine H1, muscarinic, and adrenergic receptor sites, that have been associated with adverse events in some other drugs in the class.

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