FDA Approves First Non-Opioid to Treat Opioid Withdrawal Symptoms
May 21, 2018   

The US FDA has approved the first non-opioid treatment for the relief of opioid withdrawal symptoms. The medication, lofexidine hydrochloride (trade name Lucemyra), is an oral, selective alpha-2 adrenergic receptor agonist that reduces the release of norepinephrine, which may lead to relief of autonomic withdrawal symptoms. Loxefidine is not approved for the treatment of opioid use disorder, but rather only to lessen the severity of withdrawal symptoms short-term (i.e., approved for use up to 14 days), and should be used as part of an broader overall treatment plan for patients with opioid use disorder. Its approval is based on the results of two randomized, double-blind, placebo-controlled trials involving 866 adults with opioid dependence who were undergoing abrupt opioid discontinuation. In the studies, patient-reported symptoms of opioid withdrawal were rated as less severe in the loxefidine group compared to the placebo group; the most common side effects were hypotension, bradycardia, somnolence, sedation, and dizziness. Loxefidine has not been studied in patients under the age of 17. The FDA is requiring 15 postmarketing studies, including animal safety studies to support longer-term use as well as studies in the pediatric population.

Press release

For more on opioid use disorder and its treatment:

This Month in Psychopharmacology
Lightning Round Cases: Treatments for Opioid Dependence (Member only)