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Not Another Opana: US FDA Panel Rejects PTI’s Remoxy On Intravenous Abuse Concerns

 
• By Sue Sutter

Studies showing oxycodone could be extracted for intravenous use troubled advisory committee members, who worried it would result in the same types of adverse public health effects that led to market withdrawal of Endo’s Opana ER; panelists also were concerned about the ability to partially defeat Remoxy’s extended-release properties by chewing the product.

FDA Advisory Committee Feature image

Concerned about the safety of intravenous abuse with Pain Therapeutics Inc.’s Remoxy (oxycodone extended-release), a US FDA advisory committee on June 26 recommended against approval of the long-acting opioid, citing a desire to avoid the kinds of adverse public health effects that led to the recent withdrawal of Endo Pharmaceuticals Inc.’s Opana ER.

Members of the anesthetic/analgesic drug products and drug safety and risk management panels voted 14-3 that the efficacy, safety and risk-benefit profile of Remoxy do not support approval.

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