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# KemPharm Files NDA Amendment on Pain Drug
- URL: https://www.fdaweb.com/kempharm-files-nda-amendment-on-pain-drug/
- Published: 2016-06-09T12:00:00.000Z
- Updated: 2026-09-14T21:08:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135895

KemPharm has filed an NDA amendment for Apadaz (benzhydrocodone hydrochloride and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The amendment is focused on providing the agency additional information KemPharm seeks to include in the FDA's current NDA review, the company says. Specifically, it seeks to strengthen the drug’s labeling related to its abuse-deterrent properties. The company says FDA is reviewing the amendment and likely will extend its user fee target date beyond the current 6/9 deadline.

The amendment presumably addresses concerns expressed by members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee when they voted last month 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.

KemPharm says it developed the drug using its proprietary Ligand-Activated Technology, which creates a new prodrug by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. “Once administered, human metabolic processes, such as those in the gastrointestinal tract, separate the ligand from the prodrug and release the parent drug, which can then provide its therapeutic effect,” it says.