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Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

The committees met jointly to discuss a 505(b)(2) new drug application (NDA) for an immediate-release (IR) oral tablet formulation of oxycodone, named MNK-812, which is formulated with the intent to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse. A majority of the joint committee, ten of 17 members, voted that MNK-812 should be approved for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. A majority of the joint committee, twelve of 17 members, voted that, if approved, MNK-812 should be labeled as an abuse-deterrent product (ADP) by the nasal route of abuse. A majority of the joint committee, ten of 17 members, voted that if MNK-812 is approved, it should not be labeled as an ADP by the intravenous route of abuse.