FDA approves first non-opioid drug for treating opioid withdrawal symptoms

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FDA on Wednesday (May 16) approved US WorldMeds LLC's Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine and its actions are believed to play a role in the symptoms of withdrawal. The statement mentions that Lucemyra is not a treatment of opioid use disorder (OUD) but a part of its management.

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.

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Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy. Before, people going through detox were given opioids which can be very addictive. The treatment is to be provided only for 14 days.

The FDA's approval of Lucemyra is supported by 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. There were safety signals, however, with some of the most common side effects from treatment being low blood pressure and slow heart rate. These include animal and in-human studies to examine long-term use of Lucemyra, potentially during a gradual opioid dose-reduction process rather than sudden removal.

Typical patients will receive three tablets taken orally four times a day at five- to six-hour intervals during the period of peak withdrawal symptoms. Also, the patient may be more sensitive to the effects of lower amounts of opioids, so they could overdose or die if they go back to using opioids to the extent that they did before they stopped using opioids. The drug can also elevate the risk of abnormal heart rhythms. Some patients received Lucemyra, and some patients received a placebo. Studies in pediatric patients will include studies of newborns with neonatal opioid withdrawal and studies of different age groups of children who have opioid withdrawal related to stopping medically-prescribed opioid drugs.

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The FDA requires a further 15 postmarketing studies to check for the safety of the drug.

The FDA allowed this application Priority Review and Fast Track assignments, and an autonomous FDA warning board bolstered the endorsement of Lucemyra at a gathering held March. The organization likewise is in charge of the wellbeing and security of our country's sustenance supply, beauty care products, dietary supplements, items that emit electronic radiation, and for directing tobacco items.

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