Advisory Panels Discuss Effect of Food Intake on Abuse-Deterrent Opioid

The FDA is concerned that patients will have trouble complying with instructions for Purdue Pharma’s oxycodone drug Avridi, as two advisory panels discussed the effect of food intake on the abuse-deterrent opioid.

Earlier this month, the Anesthetic and Analgesic Drug Products Advisory and the Drug Safety and Risk Management Advisory Committees voted against Purdue’s NDA for immediate-release Avridi (oxycodone), which is designed to absorb slowly when taken with food.

Purdue proposed labeling that says Avridi should be taken on an empty stomach, but the FDA is concerned patients may have difficulty finding a time window to take the drug, since it is meant to be dosed every four to six hours.

A clinical study comparing patients who received either Avridi or Roxicodone after eating a high fat, high calorie meal showed the drugs were bioequivalent in terms of extent of absorption, but patients in the Avridi arm had lower peak oxycodone concentrations and a delay in time to peak oxycodone concentrations.

As a result, Purdue proposed that Avridi be taken without food. Purdue also conducted studies to determine the effects of noncompliance with the fasting regimen, and concluded that patients who take Avridi would likely have no adverse effects.

Purdue withdrew its sNDA for a reformulated extended-release OxyContin in July, forcing the FDA to cancel a joint meeting of the same two advisory committees. At the time, the drugmaker said it needed more time to analyze epidemiological data on the ER version. That application has not been resubmitted.

Read the FDA’s briefing document here: www.fdanews.com/9-15-FDA-Briefing.pdf. Purdue’s briefing document is available at www.fdanews.com/9-15-Purdue-Briefing1.pdf. — Jonathon Shacat