Vycavert hydrocodone bitartrate/acetaminophen regulatory update

Acura said FDA denied on procedural grounds the company's formal dispute resolution request to the agency for Vycavert, the biotech's abuse-deterrent formulation of hydrocodone bitartrate and acetaminophen to treat pain. The biotech said the dispute pertains to the agency's determination that nasal snorting abuse of hydrocodone with acetaminophen products "lacks relevance," thus making Vycavert ineligible for abuse deterrent labeling regardless of its abuse-deterrent profile. Acura said it is assessing its strategy for Vycavert, which could include an appeal of FDA's decision. ...