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FDA approves non-opioid treatment for opioid withdrawal



(HealthDay) -Lucemyra (lofexidine hydrochloride) has been described by U.S. Pat. Food and Drug Administration approved for the treatment of symptoms of opioid withdrawal.

Lucemyra, an oral, selective alpha-2-adrenergic receptor agonist, limits the body's production of norepinephrine, the hormone believed to play a role in the symptoms of opioid withdrawal, according to the FDA.

The safety and efficacy of Lucemyra have been validated in two randomized, double-blind, placebo-controlled clinical trials involving 866 adults who were physically dependent on opioids and abruptly discontinued opioids. Compared with placebo, Gossop scores for short opiate withdrawal scores were lower in patients treated with Lucemyra and more patients completed treatment in the Lucemyra group compared to the placebo group.

The agency stressed that Lucemyra is not specifically licensed Opioid Use Disorder, and the use of the drug should not take longer than 1

4 days. Lucemyra side effects can be hypotension, bradycardia, drowsiness and dizziness. Less common reactions may be fainting and cardiac arrhythmias. The drug was not evaluated in people under 17, the FDA said. The agency added that 15 additional studies in both humans and animals were needed to evaluate factors such as long-term use and the effect of the drug on the liver.

Lucemyra is described by U.S. Pat. WorldMeds, based in Louisville, Kentucky, USA.


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