FDA to Assess Potential Misuse of Reformulated OxyContin
The FDA’s Drug Safety Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committees will meet jointly in early July to discuss whether postmarket studies of reformulated OxyContin extended-release tablets show reduced misuse and abuse of the blockbuster pain reliever.
The FDA approved updated labeling for the reformulation in April 2013, and essentially extended Purdue Pharma’s exclusivity through 2025 when it said it would not accept or approve any ANDAs that relied on the original version of OxyContin (DID, Apr. 16, 2013). New information on the label was reflected in the section on drug abuse and included a subsection on abuse deterrence studies and a summary of study results.
At the time, the FDA said that reformulated OxyContin will make abuse by injection difficult and also reduce abuse by snorting. The agency promised to continue postmarket assessments and to release details as data become available.
Since then, other firms have sought to market abuse-deterrent opioid painkillers.
Earlier this month, a Canadian firm announced plans to file an NDA for its Rexista XR within the next year after receiving FDA notification that a Phase III clinical trial will not be necessary. Intellipharmaceutics says the FDA based its decision on data from three Phase I trials that showed the drug to be the bioequivalent to OxyContin. The company took advantage of the 505(b)(2) pathway allowing it to submit an NDA for a new drug based off a reference product.
The meeting is scheduled for July 7-8 at the FDA’s White Oak Campus in Silver Spring, Md. View the Federal Register notice at www.fdanews.com/05-29-14-oxycontin.pdf. — John Bechtel