(Reuters) – The U.S. Food and Drug Administration on Wednesday approved here the first non-opioid drug that will help reduce symptoms of opioid withdrawal in adults.
The drug, Lucemyra, is an oral treatment from US WorldMeds LLC, and is only approved for treatment of up to 14 days.
Opioid withdrawal includes symptoms — such as anxiety, agitation, sweating, vomiting, diarrhea and drug craving — that occur after stopping or reducing the use of opioids.
The application was granted priority review and fast track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held in March.
The approval comes at a time when the United States is facing an opioid epidemic.
Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention.
Lucemyra is not a treatment for opioid use disorder (OUD), but can be used to manage OUD as part of a long-term plan, the drugs regulator said.
Reporting by Mrinalini Krothapalli; Editing by Sriraj Kalluvila