Lucemyra™ Approved to Alleviate Opioid Withdrawal Symptoms

By Michael Nguyen
PharmD, CPh, Director of Clinical Services

The U.S. Food and Drug Administration (FDA) recently approved Lucemyra™ (lofexidine). Lucemyra is FDA-approved to lessen the symptoms of opioid withdrawal for adults who stop taking opioids. Symptoms of opioid withdrawal include mood changes, muscle aches, nausea and vomiting, sleep disturbances and sweating. It is estimated that over two million Americans have an opioid use disorder, but fewer than 20% are being treated.

This medication should be integrated into a comprehensive treatment plan that also includes behavioral components such as psychosocial support through counseling, peer groups and supervision. It is the first non-opioid drug to be FDA approved for opioid withdrawal. Lucemyra is part of a class of medications known as alpha2-adrenergic agonists which includes clonidine, which is indicated for ADHD and hypertension. Clonidine is known to be used off-label for opioid withdrawal with data showing efficacy towards decreasing the severity and duration of opioid withdrawal.[1]

Previously available U.S. medication options include buprenorphine, methadone and naltrexone which are meant to be used long-term and not just for acute withdrawal. Lucemyra is indicated for acute withdrawal and should not be used for longer than two weeks. 

The recommended dosing is three tablets taken every five to six hours each day for one week and then tapered down as symptom severity decreases. No more than 16 tablets should be taken in any 24-hour period. Expected availability is August 2018, but pricing information is not currently available. Complete prescribing information for Lucemyra is available here.



[1] Gowing L, Farrell M, Ali R, White JM. Alpha₂-adrenergic agonists for the management of opioid withdrawal. Cochrane Database Syst Rev. 2016:3;(5):CD002024.