BRIEF—FDA calls for more data on Alkermes ALKS 5461 NDA

Following a negative advisory panel vote last November, Ireland-incorporated Alkermes has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for ALKS 5461 (buprenorphine/samidorphan) for the adjunctive treatment of major depressive disorder (MDD).

The CRL states that the FDA is unable to approve the ALKS 5461 NDA in its present form and is requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the adjunctive treatment of MDD.

Alkermes plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the Agency will inform whether there is a viable path forward for the ALKS 5461 program.

The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.

The Dublin-headquartered firm, which has a lot invested in the candidate, faced turbulence last year when the US regulator refused its initial application for the therapy, before having an immediate change of heart.