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Trials & Filings

Alkermes MDD Drug Gets Fast Tracked

FDA accelerates review process

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Alkermes has received Fast Track status from the FDA for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard therapies. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and with the potential to address an unmet medical need.

ALKS 5461 consists of buprenorphine, a partial agonist, and ALKS 33, a potent mu-opioid antagonist, and is designed to be a once-daily, non-addictive medicine. Early clinical development of ALKS 5461 was funded through a grant from the National Institute on Drug Abuse.

“We are extremely pleased to have been conferred Fast Track status for ALKS 5461 as we believe that ALKS 5461 may represent an important option for the treatment of major depressive disorder,” said Elliot Ehrich, Chief Medical Officer of Alkermes. “This designation supports our position that there is a clear and compelling need for a novel mechanism for the treatment of depression.”

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