News Feature | July 10, 2014

Purdue Pharma's HYD Pain Drug Receives FDA Priority Review

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) has granted Priority Review to Purdue Pharma’s once-daily hydrocodone bitartrate tablet (HYD) with abuse-deterrent properties.

Purdue’s HYD is a single entity painkiller medication formulated with properties to discourage intentional misuse or abuse of the drug through several routes of administration, such as injection, snorting, or chewing. Hydrocodone combination products are among the most commonly prescribed opioid analgesics in the U.S., as well as the most abused.

Todd Baumgartner, VP of Regulatory Affairs and CMO at Purdue Pharma, said, “It is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualized care. 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.” The company recently presented research data for HYD tablets at the American Pain Society 33rd Annual Scientific Meeting held in Tampa, Florida last April.

The FDA grants Priority Review to New Drug Applications (NDA) with potential to improve safety and efficacy of treatment, prevention, or diagnosis of serious conditions and diseases compared to standard therapy options. Mark Timney, President and CEO of Purdue Pharma, said that the designation is a milestone in the company’s efforts to build a portfolio of pain medications with abuse-deterrent technology in the interests of public health.

With the Centers for Disease Control and Prevention reporting that prescription painkillers are linked with 46 deaths every day, criticism of investigational painkiller drugs have been voiced by addiction advocates and lawmakers. Recently both the FDA and drug maker Zogenix has come under fire regarding the hydrocodone medication Zohydro, which has been initially filed as a painkiller drug without abuse-deterrent properties. Zogenix filed an abuse-discouraging formulation for Zohydro last week.

In view of the Priority Review status, Purdue said it expects a target action date for its application by October of this year.