FDA Rescinds Refusal to File on Alkermes’ Depression Drug

Following a two-week hold, the U.S. Food and Drug Administration (FDA) has accepted Alkermes’ New Drug Application (NDA) for ALKS 5461—a novel, once-daily medication for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressants. ALKS 5461 is a fixed-dose combination of two opioid compounds, buprenorphine and samidorphan.

The FDA had initially sent a Refusal to File letter to Alkermes stating that the NDA contained insufficient evidence of overall effectiveness for the proposed indication of MDD, and that additional well-controlled clinical trials were needed prior to the resubmission of the NDA.

In a statement released by Alkermes, the company noted it had productive interactions with the FDA to clarify certain aspects of its NDA submission, which contained data from more than 30 clinical trials involving more than 1,500 patients with MDD. The FDA has now rescinded the refusal letter without requiring additional trials. ■