FDA Approves First Non-Opioid Drug for Opioid Withdrawal

Following a priority review, the US Food and Drug Administration (FDA) has approved the oral selective alpha 2-adrenergic receptor agonist Lucemyra (lofexidine hydrochloride) for the alleviation of opioid withdrawal symptoms in adults.

The drug is approved for up to 14 days of use and may help lessen the severity of withdrawal symptoms, such as agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea, and drug craving.

The FDA’s Psychopharmacologic Drugs Advisory Committee first voted 11-to-1 to recommend the approval of Lucemyra in March.

Commonly reported side effects of Lucemyra include hypotension, bradycardia, somnolence, sedation, and dizziness. In few cases, syncope was also reported.

Although Lucemyra can serve as a component of a broader, long-term treatment plan for opioid use disorder (OUD), it is not a treatment for OUD, the FDA said.

—Christina Vogt

Reference:

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults [press release]. US Food and Drug Administration. May 16, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607884.htm?utm_campaign=05162018_PR_FDA approves non opioid treatment for opioid withdrawals&utm_medium=email&utm_source=Eloqua Accessed on May 17, 2018