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# KemPharm Seeks Dispute Resolution of Pain Drug Denial
- URL: https://www.fdaweb.com/kempharm-seeks-dispute-resolution-of-pain-drug-denial/
- Published: 2016-09-19T12:00:00.000Z
- Updated: 2026-09-14T21:33:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136837

KemPharm has decided to file a formal dispute resolution request over a June FDA complete response letter on an NDA label claim of abuse deterrence for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The company expects it could take up to 12 months to complete all parts of the dispute resolution request.

The complete response letter was in response to an NDA amendment that the company filed earlier this year ([see story](https://www.fdaweb.com/kempharm-files-nda-amendment-on-pain-drug/)) that sought to strengthen the drug’s labeling related to its abuse-deterrent properties. The amendment presumably addressed concerns expressed by members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee when they voted in May 16-4 to recommend approval for the drug. 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 decided to seek dispute resolution in order to address and resolve certain disagreements with CDER’s interpretation of the “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” and the data provided within the Apadaz NDA related to its abuse-deterrence properties. The issues for the dispute resolution are “solely related to the abuse-deterrence properties of Apadaz and what constitutes abuse-deterrence in the context of a label claim,” it says.

Minutes from an end-of-review meeting also confirmed that the review division is focused primarily on “Category 3 data in determining whether an IR opioid product is eligible for any abuse-deterrent label claims,” the company adds. “Though we believe the data submitted in the Apadaz NDA supported important elements of the Category 3 criteria, the data did not meet the endpoints of greatest relevance to the division,” it says.

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.