The FDA has approved Lucemyra (lofexidine hydrochloride), a non-opioid, to help lessen the symptoms of opioid withdrawal in adults.
Oral lofexidine, a selective alpha 2-adrenergic receptor agonist that inhibits the release of norepinephrine, is approved for up to 14 days of treatment. The FDA notes that it doesn’t treat opioid use disorder, but it can be used as part of an overall treatment plan. Also, lofexidine may not completely prevent withdrawal symptoms.
Approval was based on two randomized trials of nearly 900 adults with opioid dependence. Patients receiving lofexidine had fewer withdrawal symptoms than placebo recipients and were more likely to complete treatment.
The FDA is mandating postmarketing studies to assess the drug’s safety. Lofexidine affects electrical activity in the heart, which could boost the risk for arrhythmias. Common side effects include bradycardia, hypotension, sedation, and somnolence. Upon discontinuing treatment, patients can see a spike in blood pressure.