First non-opioid treatment for withdrawals gets FDA approval


The Food and Drug Administration (FDA) has approved the first non-opioid therapy for the management of opioid withdrawal symptoms. "The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help".

The opioid addiction market got a new player Wednesday with the FDA approval of Lucemyra, a pill that helps patients manage symptoms of withdrawal. The drug can also elevate the risk of abnormal heart rhythms. Since last April, when the Department of Health and Human Services announced its five-point plan for tackling the opioid crisis, just one novel pain treatment has gained FDA approval: Flexion Therapeutics' Zilretta (triamcinolone acetonide extended-release), a non-opioid option for osteoarthritis knee pain. The safety and efficacy of Lucemyra have not been established in children or adolescents less than 17 years of age.

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.

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Symptoms of opioid withdrawal vary. And those who seek assistance may relapse due to continued withdrawal symptoms. For opioids, withdrawal symptoms can include runny noses, sleep problems, sweating, nausea, vomiting and more.

The non-opioid medication, also known as lofexidine hydrochloride, could allow people take a crucial step toward getting off heroin or prescription opioids. 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 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. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly. The agency added that it's requiring 15 additional studies in both people and animals to evaluate factors such as longer-term use and the drug's effects on the liver. 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.