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# Reviewers Question Alkermes Depression Combo Drug
- URL: https://www.fdaweb.com/reviewers-question-alkermes-depression-combo-drug/
- Published: 2018-10-30T12:00:00.000Z
- Updated: 2026-09-15T00:41:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142701

Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meet 11/1 to consider issues involved in the CDER review of an Alkermes NDA for a combination product containing buprenorphine and samidorphan intended to be used as an adjunct to established antidepressant pharmacotherapy in treating major depressive disorder. If approved, it would be the first in a new class of drugs for major depressive disorder.

In advance of the meeting, FDA released a [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM624537.pdf?ref=fdaweb.com) in which CDER medical reviewers questioned the company’s data, the trial design that was used, and the drug’s safety profile since it contains an opioid. The reviewers say the clinical trials submitted by the company had mixed efficacy results and relied on a switch in the statistical analysis plan to achieve an overall positive result.

The Alkermes drug reportedly balances opioid receptors in the brain by combining an opioid drug (buprenorphine) with a chemical (samidorphan) that is meant to counteract the addictive properties. The company says its drug performed that way in clinical testing, but observers say the approach is controversial given the nation’s opioid epidemic. Agency scientists say it has not been conclusively proven that samidorphan can totally negate the negative effects of opioids and that there has been evidence of a mild opiate effect in testing.

Panel members are being asked to consider: 

- whether substantial evidence of effectiveness has been presented;
- whether the drug’s safety profile has been adequately characterized;
- whether there are concerns about potential misuse, abuse, addiction, or overdose; and
- whether the available data support a favorable risk/benefit profile to support approval.