Acura Pharma Submits Formal Dispute Resolution Request With FDA - Quick Facts

(RTTNews) - Acura Pharmaceuticals Inc. (ACUR) reported submitting a formal dispute resolution request with the FDA for Vycavert, its abuse deterrent formulation of hydrocodone and acetaminophen tablets. The dispute relates to the FDA's determination that nasal snorting abuse of hydrocodone with acetaminophen products lacks relevance.

As a result of this action, Acura is availing itself of the FDA's established appeal process whereby disagreements with conclusions reached by a reviewing Division within the FDA are reviewed above the Division level. FDA guidance stipulates that the FDA respond within 30 days.

Acura hopes that the available data, as contained in the multiple sources provided to the FDA, strongly supports the conclusion that hydrocodone containing products are known to be abused through snorting, a standard explicitly identified in FDA's January 2013 "Guidance for Industry Abuse-Deterrent Opioids -- Evaluation and Labeling". It further believes that such route of abuse results in hospitalizations and poses a significant public health issue. There can be no assurance that the dispute resolution will be successful.