Purdue Pharma Granted Priority Review Designation for Abuse-deterrent Hydrocodone Tablet

Posted July 18, 2014

By Michael Johnsen - Published In Drug Store News (edited)


STAMFORD, Conn. — Purdue Pharma recently announced that the Food and Drug Administration has granted priority review designation for the company's once-daily, single-entity hydrocodone bitartrate tablet.


The investigational pain medication was formulated to incorporate abuse-deterrent properties designed to make the product more difficult to manipulate for the purpose of misuse or abuse by various routes of administration (e.g., chewing, snorting and intravenous injection). 


Purdue conducted a series of manipulation and extraction studies and clinical abuse liability studies to evaluate the abuse-deterrent properties of this investigational formulation. The data from these studies were recently presented at the 33rd Annual Scientific Meeting of the American Pain Society. 


Hydrocodone combination products are one of the most commonly prescribed opioid analgesics in the United States, the company noted. These products are also the most widely abused (nonmedical use), according to the Substance Abuse and Mental Health Services Administration. Currently available hydrocodone formulations do not incorporate abuse-deterrent technologies, Purdue Pharma stated