FDA Grants Priority Review Designation for Purdue Pharma's Once-Daily Hydrocodone Bitartrate Extended-Release Tablets Formulated with Abuse-Deterrent Properties

FDA Grants Priority Review Designation for Purdue Pharma's Once-Daily Hydrocodone Bitartrate Extended-Release Tablets Formulated with Abuse-Deterrent Properties

Anticipated FDA action set for October 2014

Stamford, Conn. – July 8, 2014 – Purdue Pharma L.P. announced that the U.S. Food & Drug Administration (FDA) has granted Priority Review designation for the company's once-daily, single-entity hydrocodone bitartrate tablet (HYD). This 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," said 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."

Priority Review is granted by the FDA to applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Designation of a drug as "Priority" does not alter the scientific/medical standard for approval or the quality of evidence necessary1. Purdue announced filing the New Drug Application (NDA) for hydrocodone bitartrate tablet (HYD) in April 2014 and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 2014.

"It is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualized care," said Todd Baumgartner, MD, MPH, Vice President of 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 States2. These products are also the most widely abused (nonmedical use), according to the Substance Abuse and Mental Health Services Administration3. Currently available hydrocodone formulations do not incorporate abuse-deterrent technologies.

1 Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review, FDA.gov. Accessed 06/30/2014
2 U.S. Pharmaceutical Sales – Q4 2013, Drugs.com, Accessed 06/26/2014
3 2012 National Household Survey on Drug Use and Health, Table 1.89A, Substance Abuse and Mental Health Services Administration. Accessed 06/26/2014

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.


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