FDA Approves First Non-Opioid For Management Of Opioid Withdrawal Symptoms

18 May, 2018, 09:26 | Author: Veronica Peterson
  • FDA approves 1st non-opioid drug to ease withdrawal symptoms

The Food and Drug Administration (FDA) has approved the first non-opioid therapy for the management of opioid withdrawal symptoms. It is essentially a selective alpha 2-adrenergic receptor agonist.

Lucemyra has been approved to treat vomiting, muscle aches, agitation, and other symptoms associated with quitting opioids. Lucemyra is similar to clonidine, which FDA staff had noted in discussing the drug with an advisory committee in March, is often used off-label for opioid withdrawal symptoms.

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. Lucemyra is now only approved for no more than 14 days of treatment.

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. 866 adults participated in the study.

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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Side effects included low blood pressure, dizziness, sleepiness, slow heart rate and, in a few people, fainting.

In patients utilizing opioid analgesics fittingly as endorsed, opioid withdrawal is regularly overseen by a moderate decrease of the prescription, which is planned to dodge or reduce the impacts of withdrawal while enabling the body to adjust to not having the opioid. 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. He added, "We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms". Some patients received Lucemyra, and some patients received a placebo.

The FDA requires a further 15 postmarketing studies to check for the safety of the drug. Studies in pediatric patients will include studies of newborns with neonatal opioid withdrawal and studies of different age groups of children who have opioid withdrawal related to stopping medically-prescribed opioid drugs.

As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution.

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