FDA Panel Recommends Approval for Non-Opioid-Based Withdrawal Medication

A Food and Drug Administration (FDA) advisory committee on March 27 voted 11-1 in favor of approving lofexidine hydrochloride to treat the symptoms of abrupt opioid withdrawal. Unlike methadone and buprenorphine, which are used to help people with opioid use disorder abstain from using opioids, lofexidine is a non-opioid drug that targets the alpha 2-adrenergic receptor.

The Psychopharmacologic Drugs Advisory Committee noted that the clinical data showed lofexidine is generally safe and effective in reducing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keeps patients from successfully withdrawing from opioids.

If approved, lofexidine will be marketed as Lucemyra by US WorldMeds. The FDA’s decision on the medication may come as early as next month. ■