FDA approves non-opioid for opioid withdrawal symptoms

The Food and Drug Administration (FDA) this week approved the first non-opioid medication for the treatment of opioid withdrawal symptoms, after an advisory panel overwhelmingly recommended approval of the medication earlier this year. Lucemyra (generic name: lofexidine) was shown to result in less severe withdrawal symptoms and to facilitate completion of a withdrawal protocol in two placebo-controlled studies.

Lucemyra, which suppresses the neurochemical surge that produces troubling symptoms of opioid withdrawal that include muscle spasms, stomach cramps and heart pounding, is expected to be available in the U.S. market in August.

Officials at drug maker US WorldMeds referred to the FDA's action as a “milestone approval,” given that the challenge of opioid withdrawal often can get overlooked in discussions of how to address the opioid crisis. The fear and pain associated with withdrawal symptoms often sends individuals back to opioid use. The FDA reviewed the drug application for Lucemyra under its priority review procedures.

Lucemyra is seen as having significant potential for patients seeking to be initiated on injectable naltrexone treatment for opioid dependence, as this requires a patient to be completely opioid-free prior to initiation.

Lucemyra is designed to be used during the period of peak withdrawal symptoms, usually occurring five to seven days after last use of opioids. The medication is given as three 0.18 mg tablets taken four times a day at intervals five to six hours apart.

The most common side effects associated with Lucemyra in clinical trials included low blood pressure, lightheadedness, slow heart rate, sleepiness and dry mouth.