FDA Panel Recommends Abuse-Deterrent Oxycodone Tablets

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The Committees voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse, but they voted 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse.

In a joint meeting, the US FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 7 to approve an investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The Committees voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse, but they voted 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse.

SpecGx, which is a subsidiary of Mallinckrodt plc , is advancing this reformulation of Roxicodone (oxycodone hydrochloride tablets USP) with properties designed to deter intravenous and intranasal abuse under the company's 505(b)2 new drug application.

"We appreciate the Committees' thoughtful review and discussion of the potential benefits our new abuse-deterrent formulation drug can bring in helping to mitigate opioid abuse and misuse," Matt Harbaugh, Executive Vice President, Chief Financial Officer and President, Specialty Generics said in a press release about the committee recommendations. "We are encouraged by the positive feedback, and will work closely with the FDA to address any questions the Agency may have."

The role of the Committees is to provide recommendations to the FDA, though the recommendations are not binding.

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