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RoxyBond Gets US Advisory Panel OK For Abuse-Deterrent Claim Despite Excipient Concerns

 
• By Michael Cipriano

Members unanimously endorse product and mostly supported abuse-deterrent language; several panelists suggest warning about possible harmful effects of excipients by abusing product intravenously.

Opioid abuse epidemic concept

The US FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee unanimously recommended Inspirion Delivery Sciences LLC's immediate release (IR) RoxyBond (oxycodone hydrochloride) for approval, but the drug might include a warning about the possible risk of excipients if abused intravenously.

The joint committee voted 19-0 in favor of approval, with one member abstaining, and also voted 19-1 that RoxyBond be...

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