FDA panels back Collegium, spurn Purdue

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 23-1 against approval of Avridi immediate-release oxycodone from Purdue Pharma L.P. (Stamford, Conn.). Separately, the committees voted 23-0 to support approval of Xtampza ER oxycodone extended-release from Collegium Pharmaceutical Inc. (NASDAQ:COLL).

In a meeting Thursday the committees discussed the feasibility of Purdue's dosing strategy for Avridi, including an increased risk of overdose from delayed absorption and analgesic effect if the product is taken with food. Purdue had proposed product labeling directing its use on an empty stomach. The immediate-release abuse-deterrent formulation of oxycodone is dosed every 4-6 hours. ...