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# Panel Gives Mixed Vote on Trevena Pain Drug
- URL: https://www.fdaweb.com/panel-gives-mixed-vote-on-trevena-pain-drug/
- Published: 2018-10-12T12:00:00.000Z
- Updated: 2026-09-15T00:37:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142579

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8 to 7 to recommend not approving Trevena’s next-generation opioid oliceridine injection, indicated for managing moderate-to-severe pain in adult patients for whom an intravenous opioid is warranted.

The mixed vote did not come as a total suprise. In a [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM622730.pdf?ref=fdaweb.com) released in advance of the meeting, FDA medical reviewers raised safety concerns. Their overall assessment of abuse-related data from clinical studies led to a finding that oliceridine has an abuse potential, overdose potential, and ability to produce physical dependence that is similar to other such treatments.

  
Trevena’s user fee review action target date is 11/2.