FDA approves first non-opioid treatment for opioid withdrawal - 3 insights

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Lucemyra is similar to clonidine, which FDA staff had noted in discussing the drug with an advisory committee in March, is often used off-label for opioid withdrawal symptoms. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days.

The pill was approved to treat adults for up to two weeks for common withdrawal symptoms like vomiting, diarrhea, muscle pain and agitation. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms. Expanding access to treatment is viewed as an important step to curbing the country's increasing overdose rates.

The FDA is requiring the completion of 15 postmarketing animal and human studies; and additional animal safety studies will be required to support longer-term use and use in children.

Lucemyra is an orally available alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, a neurotransmitter that plays a key role in many opioid withdrawal symptoms.

FDA Commissioner Scott Gottlieb commented on the approval, saying, "as part of our commitment to support patients struggling with addiction, we're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids". The symptoms can inflict patients who are using opioids as instructed by a physician, and those patients who are addicted to it. Patients can experience any combination of these symptoms after ceasing opioid use. The wellbeing and adequacy of Lucemyra was upheld by two randomized, twofold visually impaired, fake treatment controlled clinical trials of 866 grown-ups meeting Diagnostic and Statistical Manual-IV criteria for opioid reliance who were physically subject to opioids and experiencing unexpected opioid end.

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For each opioid withdrawal symptom, patients are asked to rate their symptom severity using four response options (none, mild, moderate and severe), with the SOWS-Gossop total score ranging from 0 to 30, where a higher score indicates a greater withdrawal symptom severity. 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. The wellbeing and viability of Lucemyra have not been built up in kids or young people under 17 years old. "I applaud the work of the FDA as well as the National Institute on Drug Abuse, which supported clinical studies of the treatment, in prioritizing efforts to prevent and treat opioid addiction".

Human studies are needed to find out how safe lofexidine is if it's used for longer than the maximum 14-day treatment period, to get more data on how safe it is for the liver, and to further study its effects on blood pressure after it is stopped.

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

Manufacturer US WorldMeds said it will market the drug as soon as this summer, under the trade name Lucemyra.

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