FDA Approves First Non-Opioid Treatment to Manage Withdrawal

FDA approves Lucemyra to treat symptoms of opioid withdrawal and help patients overcome addiction

FDA approves Lucemyra to treat symptoms of opioid withdrawal and help patients overcome addiction

Withdrawal symptoms from opioids are often very hard to manage, but the approval of a new treatment could change all of that for patients.

The drug, which has been used in the United Kingdom for more than two decades now, is made by Louisville, KY-based US WorldMeds.

The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic, The Associated Press reported.

For those addicted to opioids, quitting cold turkey can be a harrowing experience.

"We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction", FDA Commissioner Scott Gottlieb says in the statement. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help.

The non-opioid medication, also known as lofexidine hydrochloride, could allow people take a crucial step toward getting off heroin or prescription opioids.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. Results showed that SOWS-Gossop scores were lower in patients who are treated with Lucemyra compared to placebo. 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. Lucemyra isn't a treatment for opioid utilize clutter (OUD), however, can be utilized as a feature of a more extensive, long haul treatment get ready for overseeing OUD.

New medication targets symptoms experienced when reducing or stopping opioids due to physical dependence. 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. At the point when Lucemyra is ceased, patients can encounter a stamped increment in the pulse.

Patients with chronic pain can attend the FDA's "Patient-Focused Drug Development for Chronic Pain" meeting on July 9 from 10 a.m.to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.

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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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