FDA Approves Lucemyra™ for Opioid Withdrawal Symptoms

In a landmark moment for opioid addiction relapse prevention, the Food and Drug Administration (FDA) has approved the first-ever non-opioid medication to treat opioid withdrawal. The agency has expedited approval of Lucemyra™ (lofexidine hydrochloride) on May 16, 2018. Originally developed to treat hypertension, Lucemyra is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal. The drug has been used for similar applications in the UK for over 20 years. Its approval was recently fast-tracked as a means of fighting the increasingly high opioid addiction rates in the United States. Lucemyra will be available in pill form this summer and sold by WorldMeds.

Part of A Comprehensive Prevention Plan

Like other opioid withdrawal medications, Lucemyra is just one component of opioid withdrawal management and is only approved for intervals of 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 most common side effects from treatment with Lucemyra include hypotension (low blood pressure), slow heart rate, sleepiness, sedation and dizziness. It has been most effective in treating withdrawal symptoms like vomiting, diarrhea, muscle pain and agitation. While it is not an addiction treatment medication, clinicians are encouraged by its ability to lessen lingering withdrawal effects.

A Potentially Effective Resource

A study of 866 adults (some of whom were given Lucemyra for their opioid withdrawal symptoms and some of whom were given placebos), this who were given Lucemyra experienced noticeably higher rates of symptom relief. The FDA is requiring WorldMeds to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids. The company has not yet set a price for the medication. The approval of Lucemyra represents the first non-opioid solution for opioid withdrawal symptoms, a distinction that has the treatment community optimistic.