LUCEMYRA, First Drug for Opioid Withdrawal Symptoms, Receives FDA Recommendation Interview with:
Mark Pirner, MD, PhD
Senior Medical Director
US WorldMeds What is the background for this study? Would you briefly explain how lofexidine works?

Response: LUCEMYRA (lofexidine) was studied in two phase 3 pivotal randomized, double-blind, placebo-controlled clinical studies, and a phase 3 open-label study. Clinical pharmacology studies included evaluation of drug-drug interaction studies that demonstrated lofexidine can be safely administered concomitantly with methadone, buprenorphine or naltrexone.

LUCEMYRA is an alpha 2 adrenergic receptor agonist that reduces the surge of norepinephrine signaling in the brain which results from abrupt opioid withdrawal, and thereby reduces the severity of opioid withdrawal symptoms. What are the main findings of the studies?

Response: The phase 3 pivotal studies demonstrated that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were almost twice as likely to complete a seven-day opioid treatment. If approved, LUCEMYRA may help people find meaningful relief from opioid withdrawal symptoms, and in turn, better manage withdrawal and progress to their post-withdrawal treatment plans. What should readers take away from your report?

 Response: Opioid withdrawal is an often-overlooked medical challenge. When symptoms of withdrawal are misunderstood or under-treated, it can present a significant barrier to successful opioid discontinuation. The Advisory Committee’s favorable recommendation brings us one step closer to potentially offering this new evidence-based medication to healthcare providers and their patients 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. Is there anything else you would like to add?

Response: There are currently no FDA approved non-opioid medications that are indicated for the mitigation of opioid withdrawal symptoms. If approved, LUCEMYRA will be the first and only non-opioid medication indicated for the mitigation of opioid withdrawal symptoms in the United States.

Citations: press release:

FDA Advisory Committee Votes in Favor of LUCEMYRA™ (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms

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Last Updated on April 4, 2018 by Marie Benz MD FAAD