FDA Rejects Alkermes’ Proposed Depression Treatment

February 4, 2019

The US Food and Drug Administration (FDA) has rejected Alkermes’ New Drug Application for ALKS 5461, a proposed adjunctive treatment for major depressive disorder, citing the need for additional clinical data exhibiting its effectiveness.

Alkermes officials plan to meet with the FDA to determine “whether there is a viable path forward for the ALKS 5461 program,” the company said in a press release.

The once-daily pill was proposed for patients who have had an inadequate response to standard antidepressant therapies. It combines buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.

The decision comes 3 months after an FDA advisory panel voted 21-2 against the drug, saying the data did not support a favorable benefit-risk profile, and FDA staff reviewers flagged its abuse potential and raised questions on its efficacy. The FDA does not have to follow advisory panel recommendations but generally does.

Alkermes said its submission “was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1500 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 company said in its statement.

—Terri Airov


Alkermes receives complete response letter from U.S. Food and Drug Administration for ALKS 5461 New Drug Application [press release]. Dublin, Ireland: Alkermes plc; February 1, 2019.