Purdue Pharma's Pain Med Gets FDA Priority Review Status
By Lori Clapper
On Tuesday, the U.S. Food & Drug Administration (FDA) granted priority review to Purdue Pharma’s once-daily, single-entity hydrocodone bitartrate tablet (HYD). The company’s investigational pain medication is designed to make it difficult for people to abuse, either through chewing, snorting, or intravenous means, according to Purdue’s announcement.
Because Hydrocodone combination products are the most widely abused, Purdue performed a series of manipulation and extraction studies as well as clinical abuse liability studies to evaluate the drug’s abuse-deterrent properties. Participants in the study experienced at least a 30 percent improvement in pain intensity, and nearly half achieved a 50 percent improvement, with side effects typical of opioid analgesics.
The company then filed its New Drug Application (NDA) for hydrocodone bitartrate tablet (HYD) in April 2014, with the FDA’s target action date set for October 2014 under the Prescription Drug User Fee Act (PDUFA).
Mark Timney, president and CEO of Purdue Pharma, believes the receipt of FDA’s priority review is an important step in this area of study. He said that it will “offer patients and health professionals a portfolio of pain medications with abuse-deterrent technology.”
Priority Review is only granted for drugs that, if approved, would offer “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” according to the FDA.
“It is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualized care,” Todd Baumgartner, MD, MPH, VP of Regulatory Affairs and CMO at Purdue Pharma, said. “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.”
Along with this latest win, Purdue will advance future solid-dosage production, with plans to build a new, 188 thousand-square-foot manufacturing facility, the Wall Street Journal says.
The plant will be built on 50 acres in Durham, N.C. and will feature clean rooms and labs, aas well as conference, and training areas.