FDA Approves First Non-Opioid Medication To Treat Withdrawal Symptoms

For the first time, the Food and Drug Administration (FDA) has approved a medication for easing the discomfort and pain of opioid withdrawal.

Lofexidine, under the brand name Lucemyra, specifically addresses the physical symptoms of quitting opioid drugs, which include anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting diarrhea, and drug craving.

Dr. Nora Volkow, director of the National Institute on Drug Abuse (NIDA), explained that such symptoms, in addition to depression and anxiety, are a huge factor in preventing people from getting well.

“Physiological and psychological withdrawal symptoms play a major role in driving users repeatedly back to the drug, despite efforts to stop using,” Volkow wrote in a blog post.

The reason that opioid drugs like OxyContin, or its illicit counterpart heroin, are so difficult to quit, is the physical dependence that develops from opioid use over time.

Trying to cut back will result in withdrawal symptoms that can start just a few hours after last taking the drug.

Dr. Scott Gottlieb, head of the FDA, noted that “These symptoms of opioid withdrawal occur in both patients who have been using opioids appropriately as prescribed and in patients with OUD (opioid use disorder).”

Unlike buprenorphine and methadone, which are FDA-approved for medication-assisted treatment (MAT)—substituting the opioid drug with a prescribed opioid to reduce dependence over time—Lucemyra is not an opioid.

By introducing a non-opioid alternative to the market, Volkow hopes that more people will have access to withdrawal relief, noting that maintenance drugs like buprenorphine and methadone “are not always easy to access, and at this point are only received by a minority of people with opioid use disorder.”

Lucemyra is only approved for treatment for up to 14 days, according to an FDA press release, and is intended not as a treatment for OUD, but “as part of a broader, long-term treatment plan for managing OUD.”

The most common side effects of the drug, originally developed for hypertension but which has been used for opioid withdrawal in the UK since the early 1990s, are hypotension (low blood pressure), bradycardia (slow heart rate), somnolence (sleepiness), sedation and dizziness.