FDA OKs first non-opioid treatment for opioid withdrawal

Leslie Hanson
May 17, 2018

"A better understanding of opioid withdrawal represents an opportunity in the prevention, treatment and recovery process for physical opioid dependence and opioid use disorder", co-author, Mark Pirner, MD, PhD, Senior Medical Director, Clinical Research and Medical Affairs, US WorldMeds, previously told MD Magazine.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", FDA Commissioner Dr. Scott Gottlieb said in a statement. Participants treated with Lycemyra experienced less withdrawal symptoms when compared to participants who took the placebo instead.

Opioid withdrawal can cause symptoms including anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving.

Withdrawal symptoms from opioids are often very hard to manage, but the approval of a new treatment could change all of that for patients.

On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms.

Lucemyra is an orally available alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, a neurotransmitter that plays a key role in many opioid withdrawal symptoms. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. The drug, called Lucemyra (lofexidine hydrochloride), will also help adults who rely on opioids for pain relief.

It will be the first drug in America to directly mitigate symptoms of withdrawal, rather than targeting their addiction. Common side effects include a slow heart rate, low blood pressure, and sleepiness. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger. The symptoms can inflict patients who are using opioids as instructed by a physician, and those patients who are addicted to it.

The FDA is requiring 15 postmarketing studies, including both animal and human studies. The approved treatment period is up to 14 days.

These come on within hours of a drug-dependent person stopping or cutting their dosage of opioids - whether it's prescribed or sought out for abuse. Additionally, an independent FDA advisory committee supported the approval at a meeting in March. Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.

The FDA granted the approval of Lucemyra to US WorldMeds LLC.

Other reports by Iphone Fresh

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