FDA Panel to Review of Mallinckrodt Abuse-Deterrent Oxycodone Formulation

Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has confirmed it will hold a joint meeting of its Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee on Nov. 14, 2018.

The Committees will assess the 505(b)2 new drug application submission for MNK-812, Mallinckrodt’s abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets with a proposed indication for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Mallinckrodt is advancing this reformulation of Roxicodone^®(oxycodone hydrochloride tablets USP) with properties designed to deter intravenous and intranasal abuse.

“We look forward to engaging with the Advisory Committees to discuss the potential benefits our new abuse-deterrent formulation technology can bring in helping to mitigate opioid abuse and misuse,” said Matt Harbaugh, Executive Vice President, Chief Financial Officer and President, Specialty Generics for Mallinckrodt.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 16, 2018, to complete its review of Mallinckrodt’sproduct.

https://www.marketscreener.com/MALLINCKRODT-PLC-13450292/news/Mallinckrodt-U-S-FDA-Announces-Joint-Advisory-Committee-Review-of-Mallinckrodt-s-Abuse-Deterrent-27385237/