FDA Nixes Alkermes’ Combo Drug for Depression

Earlier this month the Food and Drug Administration (FDA) rejected Alkermes’ new drug application for ALKS 5461, a combination pill containing samidorphan and buprenorphine intended for adjunctive treatment for major depressive disorder. According to a release issued by Alkermes, the FDA requested additional data to provide substantial evidence of the drug’s effectiveness.

The decision by the FDA to reject ALKS 5461 came months after an advisory panel recommended against approval of the medication. In an FDA briefing document, the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee described concerns over whether chronic exposure to the drug would increase the risk of opioid dependence, misuse, and abuse, and whether it would be possible for individuals who want to misuse the buprenorphine component to chemically separate it from the samidorphan in the pills.

The company said it plans to meet with the FDA to discuss potential next steps for ALKS 5461. ■