Sunovion, Otsuka partner to study treatment for bipolar-linked major depressive episodes

Sunovion and Otsuka announced the first patient has been randomly assigned in their phase 3 clinical study of non-racemic amisulpride for treating major depressive episodes linked to bipolar I disorder.

Sunovion, its parent company Sumitomo Dainippon Pharma, and Otsuka are jointly developing and commercializing the treatment (SEP-4199). Researchers on the 6-week, global, multicenter RELEASE 1 study will examine the efficacy, safety and tolerability of this treatment among adults with bipolar depression. Participants will be randomly assigned to receive 200 mg or 400 mg per day of fixed-dose SEP-4199 or placebo. Reduction of depressive symptoms measured via change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, compared with placebo, after 6 weeks of treatment will serve as the primary endpoint. After participating in the 6-week study period, those who complete RELEASE 1 will be eligible for enrollment in RELEASE 3, a 12-month, open-label extension study examining the long-term safety, tolerability and effectiveness of SEP-4199.

“Major depressive episodes associated with bipolar I disorder have a profound impact on those living with the condition,” Armin Szegedi, MD, PhD, senior vice president and chief medical officer at Sunovion, said in a press release. “Depressive episodes are associated with mood impairment, fatigue, loss of interest in activities or social situations and, in some cases, suicidality. We are encouraged by our phase 2 clinical results and look forward to enhancing our understanding of non-racemic amisulpride and its potential to help address unmet needs in the treatment of bipolar depression."