FDA Rejects Mallinckrodt's Abuse-Deterrent Roxicodone Reformulation
核心洞察
The FDA issued a Complete Response Letter for SpecGx LLC's abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets.
The agency provided guidance on areas needing further evaluation before the NDA can be resubmitted for potential approval.
Mallinckrodt plans to meet with the FDA to discuss the letter and explore pathways for approval, emphasizing the drug's potential to mitigate opioid abuse.
SpecGx LLC, a subsidiary of Mallinckrodt plc, has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for an abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets, USP. The drug was intended for the management of pain (搜索) severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
The FDA's letter outlines areas requiring further evaluation before the NDA can be resubmitted for review and potential approval. The reformulated Roxicodone was designed with properties to deter intravenous and intranasal abuse, under the company's 505(b)2 new drug application MNK-812.
Matt Harbaugh, President of Specialty Generics, stated, "We are evaluating the FDA's letter and will request a meeting in the coming weeks to discuss it further. We continue to believe this new abuse-deterrent formulation has the potential to mitigate opioid abuse and misuse, and though we're disappointed by the FDA's decision, we will continue to pursue a pathway to try to gain approval of the drug."
Mallinckrodt has invested in programs aimed at preventing prescription drug diversion and abuse, including abuse-deterrent technology, donation of drug disposal pouches, and collaboration with policymakers and law enforcement.