Non-Opioid Treatment Approved for Opioid Withdrawal

Lucemyra (lofexidine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat symptoms of opioid withdrawal.

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Withdrawal from an opioid painkiller can trigger symptoms including anxiety, agitation, sleep problems, muscle aches, sweating, nausea, diarrhea and drug craving. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said.

But in some cases, especially among people with opioid addiction (what the agency calls Opioid Use Disorder, or OUD), another opioid medication is substituted and its dose gradually reduced.

Lucemyra, among a class of drugs called selective alpha 2-adreneric receptor agonists, limits the body's output of norepinephrine. This hormone is believed to play a role in symptoms of opioid withdrawal, the FDA said.

"We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction," said FDA Commissioner Dr. Scott Gottlieb. "The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments."

The agency stressed that Lucemyra is not specifically approved for Opioid Use Disorder, and the drug's use shouldn't extend beyond 14 days.

Lucemyra's side effects could include low blood pressure, slowed heart rate, sleepiness and dizziness. Less common reactions could include fainting and abnormal heartbeat.

The drug has not been evaluated in people under age 17, the FDA said. The agency added that it's requiring 15 additional studies in both people and animals to evaluate factors such as longer-term use and the drug's effects on the liver.

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Lucemyra is produced by US WorldMeds, based in Louisville.

More information

The FDA has more about this approval.


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