FDA Approves First Non-Opioid Treatment to Manage Withdrawal

Robert F. Bukaty  AP

Singapore- The U.S. Food and Drug Administration approved privately held US WorldMeds LLC's Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. "The lofexidine data demonstrate that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were significantly more likely to complete opioid withdrawal treatment".

The drug is not for treating opioid use disorder but can be used as part of a long-term plan for managing it, the agency added.

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Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions. Lucemyra is now only approved for no more than 14 days of treatment.

Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments". 866 adults participated in the study. These side effects incorporate feeling wiped out, stomach issues, muscle fits/jerking, feeling of coldness, heart beating, strong pressure, a throbbing painfulness, yawning, runny eyes and a sleeping disorder/issues dozing. It is not approved as a treatment for opioid use disorder. These symptoms of opioid withdrawal occur both in patients who have been using opioids appropriately as prescribed and in patients with OUD. This committee received public input from patients who use opioids to manage their chronic pain. The drug can also elevate the risk of abnormal heart rhythms.

The safety and efficacy of Lucemyra have not been established in pediatric patients 17 years of age.

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The FDA granted Lucemyra the go-ahead after previous priority review and fast track designations, and it comes after an independent scientific panel voted 11-1 in favor of its approval.

As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids. 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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