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# Advisors Recommend KemPharm’s Apadaz
- URL: https://www.fdaweb.com/advisors-recommend-kempharms-apadaz/
- Published: 2016-05-06T12:00:00.000Z
- Updated: 2026-09-14T21:00:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135593

Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee voted 16-4 to recommend the safety and efficacy of KemPharm’s Apadaz (benzhydrocodone/acetaminophen oral tablets) for an indication of short-term (up to 14 days) management of acute pain. During the committee meeting, FDA asked the advisors to vote on whether data submitted by the company support a labeling claim that Apadaz is an abuse-deterrent product. On an 18-2 vote, committee members said Apadaz should not be labeled as abuse-deterrent. They acknowledged that the available data suggest the potential for a marginal benefit in preventing abuse via the intranasal route and encouraged the company to continue studying the drug’s abuse-deterrent properties to acquire data that in the future could reach the standards needed for a labeling claim.