FDA clears new tool in fight against opioid epidemic

Drug withdrawal symptoms can now be eased by a new nonopioid treatment approved by Federal regulators on Wednesday, the first to ease withdrawal from quitting addictive opioids. In patients with OUD, withdrawal is typically managed by substitution of another opioid medicine, followed by gradual reduction or transition to maintenance therapy with FDA-approved medication-assisted treatment drugs such as methadone, buprenorphine or naltrexone; or by various medications aimed at specific symptoms, such as over-the-counter remedies for upset stomach or aches and pains.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine.

US WorldMeds anticipates that Lucemyra's use will go beyond those who are full-fledged addicts. At present the new drug has been granted Priority Review and Fast Track approval. These studies included a total of 866 adults who met the criteria for Diagnostic and Statistical Manual-IV criteria for opioid dependence and who were undergoing an abrupt opioid withdrawal process.

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

US WorldMeds - a former Vogt Award victor in Louisville - "has been developing the data needed for FDA approval for over 10 years", he said, adding, "Being a Louisville-based company is a main priority and one of the core mission visions of US WorldMeds". SOWS-Gossop scores were lower for patients treated with Lucemyra compared to placebo, and more patients completed the treatment period of the studies in the Lucemyra group compared to placebo. Reported adverse side effects include low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms.

"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 safety and efficacy of Lucemyra have not been established in children or adolescents under age 17. Additionally, an independent FDA advisory committee supported the approval at a meeting in March. Although it is not an addiction medicine, it can be part of a longer-term treatment plan, according to the FDA. The FDA mandated an additional 15 post-market studies of the drug, including more pre-clinical safety trials that will be necessary for label expansions. The organization likewise is in charge of the wellbeing and security of our country's sustenance supply, beauty care products, dietary supplements, items that emit electronic radiation, and for directing tobacco items.


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