FDA Advisory Committees recommended approval of abuse deterrent reformulation of Roxicodone by the nasal route to manage severe pain.- SpecGx / Mallinckrodt.
SpecGx LLC , a subsidiary of Mallinckrodt plc, that operates its Specialty Generics business, announced that, in a joint meeting, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 7 to approve the SpecGx 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.
Additionally, the Committees voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse. The Committees also voted 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse.
SpecGx 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 MNK-812.
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