STAMFORD, Conn. — Purdue Pharma on Tuesday 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).
"This is another milestone in our effort to offer patients and health professionals a portfolio of pain medications with abuse-deterrent technology," stated Mark Timney, president and CEO of Purdue Pharma. "I'm proud of Purdue's leadership in advancing this important area of pharmaceutical innovation for the benefit of public health."
"It is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualized care," added Todd Baumgartner, VP regulatory affairs and chief medical officer at Purdue Pharma. "If approved by the FDA, this product will be a valuable therapy for treating chronic pain, and it is also designed to deter misuse and abuse by various routes of administration."
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.