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Opioid Withdrawal Product Moves Toward Market

March 29, 2018
FDA committee recommends lofexidine to manage symptoms

A PPM Brief

An FDA committee has recommended approval of lofexidine, a selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, for the mitigation of opioid withdrawal symptoms, according to a March 27 news release

The agency committee reviewing the product, the Psychopharmacologic Drugs Advisory Committee, is based on results included in developer US WorldMeds’ (Louisville, KY) new drug application (NDA) for its brand product Lucemyra, which is currently under priority review by FDA, according to the release. The phase 3 product has undergone two randomized, double-blind, placebo-controlled trials demonstrating safety and efficacy.

"Today’s favorable recommendation brings us one step closer to providing evidence-based medication, and hope for recovery, to people who want to discontinue opioid use and are struggling with the agonizing symptoms of opioid withdrawal, one of the most powerful factors driving opioid dependence and addictive behaviors," said Mark Pirner, MD, PhD, senior medical director, in the release.

An FDA decision is expected in the second quarter of this year.

Update 6/26/2018: FDA approved Lucemyra on May 16, 2018 as the first and only non-opioid medication for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. US WorldMeds, LLC and Salix Pharmaceuticals (Raleigh, NC) have entered into an exclusive agreement to co-promote Lucemyra. Click here to learn more. 

Last updated on: August 28, 2018
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