MNK-812

MNK-812 is an abuse-deterrent formulation (ADF) of immediate-release oxycodone hydrochloride developed by SpecGx, a subsidiary of Mallinckrodt Pharmaceuticals. It is intended for the management of pain severe enough to require an opioid analgesic for which alternative treatments are inadequate. The formulation incorporates physical and chemical barriers to deter common methods of abuse, including crushing for intranasal use and dissolution for intravenous injection. The tablets are designed to be hard and non-brittle, contain nasal irritants, and form a viscous gel when mixed with solvents. In 2018, despite a positive recommendation from FDA advisory committees, the FDA issued a Complete Response Letter (CRL) for the New Drug Application, requesting additional data.

Other names

oxycodone hydrochlorideoxycodone HCl