Forest Labs, Gedeon Richter Report Phase IIb Topline Results For Cariprazine

(RTTNews) - Forest Laboratories, Inc. (FRX) and Gedeon Richter Plc reported positive topline results from a Phase IIb study assessing the efficacy and safety of the investigational antipsychotic cariprazine in patients with bipolar depression.

Cariprazine, an investigational drug, is an orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist atypical antipsychotic. It has a low affinity at other receptor sites such as 5-HT2C, muscarinic, and adrenergic receptor sites.

The trial included four treatment groups: cariprazine 0.75 mg/day, 1.5 mg/day, 3.0 mg/day, and placebo. Statistically significant improvements were observed in the cariprazine 1.5 mg/day group relative to placebo at 6 weeks for the primary endpoint, the Montgomery-Asberg Depression Rating Scale total score and the key secondary endpoint, the Clinical Global Impressions - Severity score.

This international, randomized, placebo-controlled, fixed-dose, 8-week Phase IIb trial evaluated the efficacy and safety of cariprazine in the treatment of patients with depressive episodes of bipolar I disorder.

Across all cariprazine doses, the most common adverse events were akathisia and insomnia.