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First non-opioid treatment for withdrawals gets FDA approval

First non-opioid treatment for withdrawals gets FDA approval

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.

Lucemyra, an oral selective alpha 2-adrenergic receptor agonist, limits the body's output of norepinephrine, the hormone believed to play a role in symptoms of opioid withdrawal, the FDA said. "The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments". Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. It is not yet declared safe in children and adolescents up to the age of 17 years. Addicts often experience weeks of vomiting, diarrhea, muscle pain and agitation when they stop using the drugs.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help".

The FDA approved the first non-opioid medication to treat opioid withdrawal in adults, in order to "facilitate abrupt discontinuation of opioids in adults", the agency said Wednesday. "And those who seek assistance may relapse due to continued withdrawal symptoms".

Lucemyra (lofexidine hydrochloride) was originally meant to be a hypertension drug. More patients in the Lucemyra group completed the treatment period of the studies vs patients in the placebo group.

In a May 16 announcement, the FDA stressed that Lucemyra isn't a treatment for opioid use disorder, but rather a potential tool for managing the disorder long-term. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.

The drug, which will be available in pharmacies across the country in August, was approved 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, according to US WorldMeds.

For each opioid withdrawal side effect, patients are requested to rate their side effect seriousness utilizing four reaction choices (none, mellow, direct and extreme), with the SOWS-Gossop add up to score extending from 0 to 30, where a higher score demonstrates a more noteworthy withdrawal indication seriousness. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

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