FDA Approves Non-Opioid Treatment for Opioid Withdrawal

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

Data from the studies revealed that those treated with Lucemyra had less severe withdrawal symptoms and were significantly more likely to complete a seven-day opioid detoxification treatment compared to individuals in the group given placebo pills. Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers.

For those addicted to opioids, quitting cold turkey can be a harrowing experience.

In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is meant to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid.

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"We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms", said FDA Commissioner Scott Gottlieb, MD. And those who seek assistance may relapse due to continued withdrawal symptoms.

While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency. Lucemyra works by reducing the release of norepinephrine, a chemical in the body believed to play a part in withdrawal symptoms. Regulatory approval was based on 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, according to the company release. The agency also is requiring 15 additional postmarketing studies to assess longer-term use and use in children and newborns. These include animal and in-human studies to examine long-term use of Lucemyra, potentially during a gradual opioid dose-reduction process rather than sudden removal.

"Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction", said Marc Fishman, medical director at Maryland Treatment Centers and assistant professor Johns Hopkins University School of Medicine, in a statement from US WorldMeds. Common side effects include a slow heart rate, low blood pressure, and sleepiness. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain. The drug has not been evaluated in people under age 17, the FDA said. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.

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