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# KemPharm Files Dispute Resolution Request of Pain Drug
- URL: https://www.fdaweb.com/kempharm-files-dispute-resolution-request-of-pain-drug/
- Published: 2016-11-03T12:00:00.000Z
- Updated: 2026-09-14T21:45:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137252

KemPharm has filed a formal dispute resolution request over a June FDA complete response letter on an NDA for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. 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 suggested 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.

KemPharm acknowledges that in the clinical development program, Apadaz did not meet FDA preferred clinically meaningful endpoints, “but we believe it did demonstrate statistically significant differences, compared to an approved non-abuse-deterrent formulation, on measures of abuse deterrence. We believe those measures are relevant for the intranasal route of abuse and, importantly, we believe these differences reflect a clinically meaningful public health benefit that physicians and patients deserve to have acknowledged in the product labeling for appropriate medical treatment decision-making.”

The company says that intranasal abuse is a relevant route of prescription drug misuse for hydrocodone combination products and that providing truthful and complete information regarding the outcome of abuse deterrence studies in product labeling is essential to ensuring prescribers have the complete information needed to make informed prescribing decisions. The dispute resolution process could take up to 12 months, it says.