FDA approves first non-opioid withdrawal treatment

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Developed under private company US WorldMeds, Lucemyra works by diminishing the release of norepinephrine, a neurotransmitter that relays feelings of pain and affects withdrawal symptoms, research suggests.

Data show that compared to placebo, participants treated with Lucemyra experienced less severe withdrawal symptoms and were significantly more likely to complete a seven-day opioid discontinuation treatment.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", FDA Commissioner Dr. Scott Gottlieb said in a statement.

Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy. Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is now approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped.

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.

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

Symptoms of opioid withdrawal vary. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain. The safety and efficacy of Lucemyra have not been established in children or adolescents less than 17 years of age. The FDA reviewed Lucemyra under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. Although it is not an addiction medicine, it can be part of a longer-term treatment plan, according to the FDA.

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