FDA Advisers Back Non-Opioid Drug for Opioid Withdrawal
In an 11-to-1 vote, the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee recommended the approval of Lucemyra (lofexidine) for the management of painful opioid withdrawal symptoms.
The FDA will consider the committee’s recommendation in its pending priority review of Lucemyra, which was submitted for approval by US WorldMeds.
If approved, the selective alpha 2-adrenergic receptor agonist would be the first non-opioid drug approved for this indication.
Before Lucemyra was submitted for FDA approval, its safety and efficacy were assesed in 2 randomized, double-blind, placebo-controlled trials and several supporting studies.
FDA advisory committee votes in favor of LUCEMYRA (lofexidine) for the mitigation of opioid withdrawal symptoms [press release]. Louisville, KY. US WorldMeds. March 27, 2018. https://www.prnewswire.com/news-releases/fda-advisory-committee-votes-in-favor-of-lucemyra-lofexidine-for-the-mitigation-of-opioid-withdrawal-symptoms-300620526.html. Accessed on March 29, 2018.