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FDA Approves First Nonopioid Treatment for Opioid Withdrawal Symptoms

18 May 2018

In late-stage testing, patients physically dependent on opioids who abruptly quit taking them reported less severe withdrawal symptoms when taking Lucemyra compared to placebo. Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers.

The FDA noted that while Lucemyra can reduce withdrawal symptoms, it has not been confirmed to prevent them, and that the treatment should not continue beyond 14 days. Lucemyra is now only approved for no more than 14 days of treatment. Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms.

US WorldMeds explained that Lucemyra "suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal".

The safety and efficacy have not been established in children or adolescents 17 years of age and younger.

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Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal.

New medication targets symptoms experienced when reducing or stopping opioids due to physical dependence. Lucemyra was approved to treat withdrawal symptoms for up to two weeks. Before, people going through detox were given opioids which can be very addictive.

While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments. 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. Notably, the application for Lucemyra received Priority Review and Fast Track designations.

Lucemyra (lofexidine hydrochloride), therefore, represents a win for both the agency and US WorldMeds, which has just a handful of marketed products.

FDA Approves First Nonopioid Treatment for Opioid Withdrawal Symptoms