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FDA Approves First Non-Opioid Treatment to Manage Withdrawal

May 17, 2018
New medication targets symptoms experienced when reducing or stopping opioids due to physical dependence.

A PPM Brief

The US Food and Drug Administration today approved lofexidine hydrochloride (Lucemyra, US WorldMeds, Kentucky) for the mitigation of opioid withdrawal symptoms in adults. The agency noted that the treatment may not completely prevent withdrawal symptoms (eg, anxiety, agitation, sleep problems, muscle aches, sweating, nausea, diarrhea, drug craving), and is only approved for use up to 14 days. The agency also pointed out that Lucemyra is not meant to treat opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD. Rather, the medication may help to alleviate withdrawal symptoms among those who have developed a physical dependence to opioids and are stopping or reducing their dosage. 

“As part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids,” said FDA Commissioner Scott Gottlieb, MD, in an agency release. “We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms.”

In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is intended to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid. In patients with OUD, withdrawal is typically managed by substitution of another opioid medicine, followed by gradual reduction or transition to maintenance therapy with FDA-approved medication-assisted treatment drugs such as methadone, buprenorphine or naltrexone; or by various medications aimed at specific symptoms, such as over-the-counter remedies for upset stomach or aches and pains. Other treatments may also be prescribed by a patient’s health care provider.

The oral, non-opioid, selective alpha 2-adrenergic receptor agonist reduces the release of norepinephrine. In its announcement, US WorldMeds explained that Lucemyra “suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal.” Regulatory approval was based on two randomized, double-blind, placebo-controlled clinical trials, an open-label study, and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone, according to the company release. Trial participants treated experienced less severe withdrawal symptoms compared to placebo and were significantly more likely to complete a seven-day opioid discontinuation treatment. Adverse side effects included low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth, said the release. The product's development was made possible through a grant from and close collaboration with the National Institute on Drug Abuse, which falls under umbrella of the US National Institutes of Health.

 

The safety and efficacy of Lucemyra have not been established in children or adolescents under age 17.  FDA has requested 15 post-marketing studies, in both animals and humans, to support longer-term use and use in children.

 

Last updated on: May 17, 2018
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Managing Opioid Use Disorders and Chronic Pain
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