NDA for Novel Major Depressive Disorder Treatment Submitted to FDA

The NDA submission is based on a comprehensive clinical efficacy and safety package with data from more than 30 clinical trials.

Alkermes announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for ALKS 5461 (buprenorphine/samidorphan), an oral drug candidate for the adjunctive treatment of major depressive disorder (MDD).

The NDA submission was supported by clinical efficacy and safety data from over 30 trials involving more than 1,500 patients with MDD. The study drug demonstrated a consistent profile of antidepressant activity, safety, and tolerability as adjunctive therapy for MDD. 

ALKS 5461 is an investigational, once-daily drug that acts as an opioid system modulator marking a unique mechanism of action for adjunctive MDD therapy. It combines a fixed dose of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist. 

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“ALKS 5461 represents the first potential treatment option with a novel mechanism of action for the treatment of depression in 30 years. We believe its unique pharmacology may provide distinct clinical benefits for the large number of patients who do not get adequate relief from first-line standard antidepressant therapy,” said Elliot Ehrich, MD, Executive Vice President, Research and Development at Alkermes. 

ALKS 5461 was granted Fast Track status by the FDA in October 2013. 

For more information call (617) 494-0171 or visit Alkermes.com.