FDA grants Priority Review designation for Purdue's hydrocodone bitartrate

Privately held US drugmaker Purdue Pharma has been granted Priority Review designation by the US Food and Drug Administration for its once-daily, single-entity hydrocodone bitartrate tablet.

This has been formulated with abuse-deterrent properties that will make it harder to misuse or abuse by chewing or injecting intravenously. Hydrocodone formulations that are currently available do not incorporate abuse-deterrent technologies.

Priority Review is a status granted by the FDA to drugs that have the potential to constitute significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard application.