FDA Panels to Determine Food Effects on Abuse-Deterrent Opioids

Two FDA advisory panels will meet next month to discuss the effect of food intake on Purdue Pharma’s and Collegium Pharmaceuticals’ oxycodone drugs.

On Sept. 10, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will consider Purdue’s NDA for immediate-release Avridi (oxycodone), which absorbs slowly when taken with food. The FDA is concerned that patients will have trouble complying with instructions to take the drug on an empty stomach every four to six hours.

The following day, the committees will review Collegium’s NDA for Xtampza ER (oxycodone), which must be taken with food to deliver the intended amount of painkiller.

In this case, the FDA wants the panels to consider the extent of the food effect on Xtampza and whether taking the drug with varying amounts of food will cause oxycodone levels to fluctuate. The agency also wants to know if the product’s abuse-deterrent features are likely to prevent abuse and if that benefit outweighs the potential risks associated with food.

Purdue withdrew an sNDA for reformulated extended-release OxyContin (oxycodone) in July, forcing the FDA to cancel a July 7-8 joint meeting of the committees. The drugmaker said it needed more time to analyze epidemiological data on the ER version.

View the Federal Register notices on Collegium and Purdue at www.fdanews.com/08-15-FDA-Opioids1.pdf and www.fdanews.com/08-15-FDA-Opioids2.pdf. — Jonathon Shacat