ALKS 5461 (samidorphan + buprenorphine) meets primary end point in phase III trial for major depressive disorder- Alkermes

Alkermes has announced positive topline results from FORWARD-5, the third phase III efficacy study to read out from the FORWARD pivotal program for ALKS 5461 (samidorphan + buprenorphine) for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. The study met its prespecified primary endpoint showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. ALKS 5461 was generally well tolerated.

In the study, ALKS 5461 2mg/2mg met the prespecified primary endpoint of significantly reducing depression scores compared to placebo, as measured by 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6) scores. ALKS 5461 2mg/2mg also demonstrated statistically significant reductions in 10-item MADRS (MADRS-10) scores compared to placebo. The 1mg/1mg dose of ALKS 5461 showed improvement in depressive symptoms in the study, but did not separate significantly from placebo. The most commonly reported adverse events for ALKS 5461 in the FORWARD-5 study were nausea, dizziness and fatigue. These findings are consistent with those observed in previously reported studies of ALKS 5461.

Alkermes will present comprehensive data from FORWARD-5 at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal. Based on these results, along with the substantial data collected to date on the efficacy and safety of ALKS 5461 for the treatment of MDD, the company plans to request a meeting with the US FDA's Division of Psychiatric Products to discuss the filing strategy for this Fast Track designated medicine.