Forest Labs, Gedeon Report Positive 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 as adjunctive treatment in adult patients with Major Depressive Disorder or MDD, who have showed an inadequate response to antidepressant therapy or ADT.

The trial included 3 treatment groups, cariprazine 1.0 - 2.0 mg/day + ADT and cariprazine 2.0 - 4.5 mg/day + ADT, and placebo + ADT. The group that received cariprazine 2.0 - 4.5 mg/day + ADT showed statistically significant growth in the Montgomery-Asberg Depression Rating Scale or MADRS total score versus placebo at 8 weeks, the primary endpoint.

The international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 8-week Phase IIb trial evaluated the efficacy, safety, and tolerability of cariprazine as adjunctive treatment in adult patients with MDD who demonstrated an inadequate response to ADT.

Cariprazine, an investigational drug, is an orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist atypical antipsychotic.