FDA approves non-opioid therapy for opioid withdrawal

(HealthDay)—Lucemyra (lofexidine hydrochloride) has been accepted by the U.S. Food and Drug Administration to deal with signs of opioid withdrawal.

Lucemyra, an oral selective alpha 2-adrenergic receptor agonist, limits the physique’s output of norepinephrine, the hormone believed to play a task in signs of withdrawal, the FDA mentioned.

The security and efficacy of Lucemyra was validated in two randomized, double-blind, placebo-controlled scientific trials of 866 adults who have been bodily depending on opioids and present process abrupt opioid discontinuation. Compared to placebo, Short Opiate Withdrawal Scale of Gossop scores have been discovered to be decrease for sufferers handled with Lucemyra, and extra sufferers completed the therapy within the Lucemyra group versus the placebo group.

The company burdened that Lucemyra isn’t particularly accepted for Opioid Use Disorder, and the drug’s use should not lengthen past 14 days. Lucemyra’s unwanted effects might embrace hypotension, bradycardia, sleepiness, and dizziness. Less widespread reactions might embrace fainting and . The drug has not been evaluated in folks below age 17, the FDA mentioned. The company added that it is requiring 15 extra research in each folks and animals to guage elements reminiscent of longer-term use and the drug’s results on the liver.

Lucemyra is produced by U.S. WorldMeds, based mostly in Louisville, Ky.

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