FDA clears new tool in fight against opioid epidemic

FDA clears new tool in fight against opioid epidemic

FDA clears new tool in fight against opioid epidemic

"We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms", said FDA Commissioner Scott Gottlieb, MD.

The NIH says these symptoms aren't directly life-threatening, but they can drive the patient back to opioid use - often overdosing after experiencing withdrawal.

"Approval today of the first non-opioid treatment for managing opioid withdrawal symptoms is a welcome step forward", HHS Secretary Alex Azar said in another news release issued Wednesday afternoon.

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The FDA conceded the endorsement of Lucemyra to US WorldMeds LLC. This was a patient-reported outcome instrument that could help patients report their symptoms after intake of the drug.

Now, thanks to an FDA approval for US WorldMeds' Lucemyra, they'll have the first drug created to fight those symptoms. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. Trial participants treated experienced less severe withdrawal symptoms compared to placebo and were significantly more likely to complete a seven-day opioid discontinuation treatment. 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.

Lucemyra is an orally available alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, a neurotransmitter that plays a key role in many opioid withdrawal symptoms. Some patients received Lucemyra, and some patients received a placebo.

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The agency stressed that Lucemyra is not specifically approved for Opioid Use Disorder, and the drug's use shouldn't extend beyond 14 days. Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms. 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 treatment had fast-track designation and was reviewed under the FDA's priority review process.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.

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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".

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