FDA panel backs extended-release painkiller, but not immediate-release one

September 15, 2015

Last week, joint FDA advisory committees

 

Last week, joint FDA advisory committees unanimously voted in favor of Collegium Pharmaceutical’s experimental opioid painkiller, which places it closer to FDA approval.

The painkiller, Xtampza ER, is oxycodone extended-release in capsule form intended for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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The FDA staff had warned that Xtampa ER should be taken with food, otherwise it had the potential for adverse effects such as overdosing. The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, however, still voted in favor of the FDA approving the new oxycodone medication.

The FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of October 12, 2015 for completion of its review of the Xtampza ER New Drug Application (NDA).

A no vote for immediate-release painkiller

The FDA panel voted 23-1 against approving Purdue Pharma’s immediate-release opioid painkiller Avridi.

The committees, acting on findings from FDA staff, were primarily worried that adverse effects and overdoses could occur if patients do not follow the requirement of the medication – it must be taken on an empty stomach. Avridi was developed to be taken every 4 to 6 hours without food. If patients took the drug with food and had inadequate pain control, they may take more of the drug, the staff warned.