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FDA greenlights first nonopioid drug for opioid withdrawal

FDA greenlights first nonopioid drug for opioid withdrawal

"The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said.

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. Specifically, the studies will investigate the safety of Lucemyra in situations where use may last beyond the 14-day recommended treatment period, as well as what the effects may be on blood pressure after the treatment is discontinued.

"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", Dr. Gottlieb said. Less common reactions could include fainting and abnormal heart rhythms.

The safety and efficacy of Lucemyra have not been established in children or adolescents under age 17. This was a patient-reported outcome instrument that could help patients report their symptoms after intake of the drug.

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

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for the treatment and alleviation of opioid symptom withdrawal symptoms in adults in whom the drugs have been withdrawn abruptly. If the score was higher the symptoms of withdrawal was deemed higher. The symptoms can inflict patients who are using opioids as instructed by a physician, and those patients who are addicted to it.

Opioid withdrawal incorporates indications for example - uneasiness, unsettling, rest issues, muscle hurts, runny nose, sweating, sickness, spewing, loose bowels and medication wanting - that happens in the wake of ceasing or lessening the utilization of opioids in anybody with physical reliance on opioids.

Use of lofexidine should be part of a long-term treatment plan for patients stopping opioids when physically dependent, the FDA and US WorldMeds indicated. The FDA also points out that these symptoms can arise in patients who are taking opioid painkillers appropriately, as well as those with opioid use disorder. "We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms". Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them.

Manufacturer US WorldMeds said it will market the drug as soon as this summer, under the trade name Lucemyra. "I applaud the work of the FDA as well as the National Institute on Drug Abuse, which supported clinical studies of the treatment, in prioritizing efforts to prevent and treat opioid addiction".

The FDA granted Lucemyra the go-ahead after previous priority review and fast track designations, and it comes after an independent scientific panel voted 11-1 in favor of its approval.

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