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Joint FDA advisory committees voted 23-1 against approving Purdue Pharma’s immediate release opioid painkiller Avridi last week.
Joint FDA advisory committees voted 23-1 against approving Purdue Pharma’s immediate-release opioid painkiller Avridi last week.
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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.
However, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee unanimously voted in favor of the FDA approving Collegium Pharmaceutical’s experimental opioid painkiller, which places it closer to FDA approval.
The painkiller, Xtampza ER, is oxycodone extended-release capsules 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.
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).
Similar to FDA staff’s warning about Avridi, the staff had said that, if the Xtampa ER was taken without food, it could lead to insufficient pain control, which could contribute to overdosing and misuse. However, the committees still voted in favor of FDA approving the new oxycodone drug.