Posted by Michael Wonder on 17 May 2018
FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
16 May 2018 - Encouraging more widespread innovation and development of safe and effective treatments for opioid use disorder remains top agency priority.
The U.S. FDA today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.
The FDA granted this application priority review and fast track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held March.
