FDA greenlights first nonopioid drug for opioid withdrawal

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

The oral, non-opioid, selective alpha 2-adrenergic receptor agonist reduces the release of norepinephrine. Plus, more patients in the Lucemyra arm completed a seven-day opioid discontinuation treatment.

Withdrawal symptoms from opioids are often very hard to manage, but the approval of a new treatment could change all of that for patients. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately be overcoming addiction.

In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is meant to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. The treatment is to be provided only for 14 days.

The treatment had fast-track designation and was reviewed under the FDA's priority review process. In two randomized, double-blind, placebo-controlled trials, 866 adult patients demonstrated the benefits and safety of the drug.

The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic, The Associated Press reported. Patients abusing the drugs can suffer more severe withdrawal symptoms, and those who intend to take Vivitrol or another addiction drug need to withdraw from opioids first. More data is also needed to determine Lucemyra's safety and efficacy profile in patients younger than 17 years of age.

"There are many people who are physically dependent, meaning if you stop it, you're going to get withdrawal symptoms", but those people may not be to the point of negative social behavior, such as stealing things or ruining relationships, said Dr. Mark Pirner, senior medical director of Clinical Research and Medical Affairs for US WorldMeds. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly. Sublocade, a monthly injection of buprenorphine, contains a mild opioid to help stymie withdrawal symptoms for addicts quitting opioid use. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA.

The FDA said it would be requiring 15 postmarketing studies on lofexidine, "including both animal and human studies" to examine whether the drug could also be used in gradual opioid tapers and in pediatric patients, and also to better understand potential effects on blood pressure and hepatic function. The approval for making the drug is granted to US WorldMeds LLC.

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