FDA approves first non-opioid treatment for opioid withdrawal

Posted May 18, 2018

These symptoms may include aches/pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning and feeling sick. 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. Studies will also take place in pediatric patients, including on newborns with neonatal opioid withdrawal and on different age groups of children.

Lucemyra is an oral, specific alpha 2-adrenergic receptor agonist that decreases the arrival of norepinephrine.

The medicine is only approved to treat adults with withdrawal symptoms for up to 14 days. SOWS-Gossop scores were brought down for patients treated with Lucemyra contrasted with fake treatment, and more patients finished the treatment time of the investigations in the Lucemyra amass contrasted with fake treatment.

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In patients utilizing opioid analgesics fittingly as endorsed, opioid withdrawal is regularly overseen by a moderate decrease of the prescription, which is planned to dodge or reduce the impacts of withdrawal while enabling the body to adjust to not having the opioid.

The FDA approved the first non-opioid treatment for opioid withdrawal symptom management in adults. Lucemyra was additionally connected with a couple of instances of syncope (blacking out). Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms.

In 2016, opioid-related overdoses in the USA led to more than 42,000 deaths-a toll that exceeded the number of people killed in vehicle crashes.

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

"There are many people who are physically dependent, meaning if you stop it, you're going to get withdrawal symptoms", but those people may not be to the point of negative social behavior, such as stealing things or ruining relationships, said Dr. Mark Pirner, senior medical director of Clinical Research and Medical Affairs for US WorldMeds.

The FDA granted this application Priority Review and Fast Track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held March. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.

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"Lucemyra offers new hope to people who want to discontinue opioid use and are struggling with the agonizing symptoms of opioid withdrawal", said P. Breckinridge Jones, chief executive officer and founder of US WorldMeds.