Allergan, Gedeon Richter Plan to Submit Cariprazine sNDA for Depression

Officials with Allergan and Gedeon Richter are reporting positive topline results for a phase 3 study of cariprazine (Vraylar) for the treatment of adults with bipolar I depression.

Cariprazine is an oral, once daily atypical antipsychotic currently approved for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3 to 6 mg/day, and for the treatment of schizophrenia in adults with a recommended dose range of 1.5 to 8 mg/day.

In the phase 3 study, cariprazine’s safety, efficacy, and tolerability was evaluated for the treatment of bipolar I depression. The trial included 488 patients who were randomly assigned to either receive cariprazine 1.5 mg/day, 3 mg/day, or a placebo. Patients underwent a no-drug screening period of approximately 7-14 days, followed by 6 weeks of double-blind treatment and a 1-week, no investigational product safety follow-up period.

The primary endpoint was met in the study for both cariprazine 1.5 mg and 3 mg dose groups. Both groups showed significantly greater improvement than with the placebo for the change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale total score.

Cariprazine was generally well tolerated in the study. Common adverse events associated with cariprazine included sedation, somnolence, dizziness, akathisia, and nausea. Five percent of patients treated with cariprazine discontinued due to adverse events compared with 2.5% of patients treated with a placebo.

Allergan plans to submit a supplemental new drug application to the FDA in 2018.

Reference

Allergan and Richer announce positive topline results from phase 3 study of cariprazine for the treatment of bipolar I depression [news release]. Dublin and Budapest. Allergan’s website. https://www.allergan.com/News/News/Thomson-Reuters/Allergan-and-Richter-Announce-Positive-Topline-Res. Accessed December 20, 2017.