FDA OKs first non-opioid treatment for opioid withdrawal

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

FDA OKs first non-opioid treatment for opioid withdrawal

A treatment to help ease opioid withdrawal got the green light from the FDA.

For each opioid withdrawal side effect, patients are requested to rate their side effect seriousness utilizing four reaction choices (none, mellow, direct and extreme), with the SOWS-Gossop add up to score extending from 0 to 30, where a higher score demonstrates a more noteworthy withdrawal indication seriousness.

US WorldMeds anticipates that Lucemyra's use will go beyond those who are full-fledged addicts. 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.

Lucemyra won its FDA nod on Wednesday based on two trials showing that the drug reduced severe withdrawal symptoms better than placebo. In as little as a few hours, patients may experience stomach cramps, muscle aches and spasms, a pounding heart, nausea, vomiting and diarrhea.

Now, thanks to an FDA approval for US WorldMeds' Lucemyra, they'll have the first drug created to fight those symptoms.

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

The FDA said that Lucemyra is only approved for up to 14 days.

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Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. "And those who seek assistance may relapse due to continued withdrawal symptoms".

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms.

The FDA is requiring the completion of 15 postmarketing animal and human studies; and additional animal safety studies will be required to support longer-term use and use in children. The agency also pointed out that Lucemyra is not meant to treat opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.

Because Lucemyra can make withdrawal process easier for patients, National Institute on Drug Abuse Director Nora Volkow, M.D., argues it could boost wider use of Vivitrol, which differentiates itself from methadone and buprenorphine, two other addiction treatments that belong to the opioid family.

The FDA allowed this application Priority Review and Fast Track assignments, and an autonomous FDA warning board bolstered the endorsement of Lucemyra at a gathering held March.

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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