FDA approves first non-opioid to treat withdrawal symptoms in adults

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

The United States Food and Drugs Administration (FDA), in a statement this week, approved a new drug Lucemyra (lofexidine hydrochloride) for the treatment and alleviation of opioid symptom withdrawal symptoms in adults in whom the drugs have been withdrawn abruptly.

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

Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions. In patients with OUD, withdrawal is regularly overseen by substitution of another opioid prescription, trailed by steady lessening or progress to upkeep treatment with FDA-endorsed medicine helped treatment medications, for example, methadone, buprenorphine or naltrexone; or by different solutions went for particular side effects, for example, finished the-counter solutions for furious stomach or a throbbing painfulness. Before, people going through detox were given opioids which can be very addictive.

It will be interesting to see whether a drug like Lucemyra competes or is used in tandem with drugs like Sublocade, the injectable version of Indivior's popular opioid use disorder drug Suboxone.




Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments". The safety and efficacy of Lucemyra was supported by two randomized, double-blind, placebo-controlled clinical trials of 866 adults meeting Diagnostic and Statistical Manual-IV criteria for opioid dependence who were physically dependent on opioids and undergoing abrupt opioid discontinuation.

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". This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent. There were a few cases of fainting or syncope and an increased risk of heart arrhythmias.

Studies in pediatric patients will be conducted on newborns with neonatal opioid withdrawal and studies of various age groups of children with opioid withdrawal related to stopping medical-prescribed opioid drugs. The studies evaluated benefit using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which is a patient-reported outcome instrument that assesses opioid withdrawal symptoms. Some patients received Lucemyra, and some patients received a placebo. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly. 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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