First Non-Opioid Drug Approved for Managing Opioid Withdrawal Symptoms

Frederick Owens
May 18, 2018

Drug withdrawal symptoms can now be eased by a new nonopioid treatment approved by Federal regulators on Wednesday, the first to ease withdrawal from quitting addictive opioids. "The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help". Additionally, the therapy has not been approved to treat opioid use disorder, but is meant to be used as part of a long-term treatment plan for the condition.

Recommended dosing for lofexidine is three 0.18 mg tablets taken orally four times daily, when patients are experiencing peak withdrawal symptoms (generally 5 to 7 days following last use of opioids, the company said in a news release).

Lucemyra is an oral medication that reduces the release of norepinephrine, which is believed to be associated with opioid withdrawal symptoms.

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

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The treatment had fast-track designation and was reviewed under the FDA's priority review process. The drug, called Lucemyra (lofexidine hydrochloride), will also help adults who rely on opioids for pain relief.

The FDA's approval of Lucemyra is supported by two randomized, double-blind, placebo-controlled clinical trials, an open-label study and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone.

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". The studies evaluated benefit using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which is a patient-reported outcome instrument that assesses opioid withdrawal symptoms. Extra creature security studies will be required to help longer-term utilize, (for example, amid a progressive opioid decrease in torment patients stopping opioid analgesics) and use in youngsters. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. At the point when Lucemyra is ceased, patients can encounter a stamped increment in the pulse.

The FDA requires a further 15 postmarketing studies to check for the safety of the drug. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said. The safety and efficacy of Lucemyra have not been established in children or adolescents less than 17 years of age. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.

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