FDA approves 1st nonopioid drug to ease withdrawal symptoms

Posted: Updated:
(US WorldMeds via AP). This undated photo provided by US WorldMeds shows Lucemyra. Federal regulators have approved the first nonopioid treatment to ease withdrawal symptoms from quitting opioids. (US WorldMeds via AP). This undated photo provided by US WorldMeds shows Lucemyra. Federal regulators have approved the first nonopioid treatment to ease withdrawal symptoms from quitting opioids.

By LINDA A. JOHNSON
AP Medical Writer

TRENTON, N.J. (AP) - Federal regulators on Wednesday approved the first nonopioid treatment to ease withdrawal from quitting addictive opioids.

The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic. Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers.

The pill was approved to treat adults for up to two weeks for common withdrawal symptoms like vomiting, diarrhea, muscle pain and agitation. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA.

People going through detox are usually given a safer opioid medicine like methadone, which eases the cravings without an intense high.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help," FDA Commissioner Dr. Scott Gottlieb said in a statement.

In two studies of 866 adults, those given Lucemyra reported less severe withdrawal symptoms when they abruptly stopped taking opioids, compared to those who were given dummy pills.

Side effects included low blood pressure, dizziness, sleepiness, slow heart rate and, in a few people, fainting.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids.

Privately held US WorldMeds said it had not yet set a price for Lucemyra.

___

Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

Copyright 2018 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

sorry to interrupt
your first 20 are free
Access to News 12 is free for Optimum, Comcast®, Spectrum Networks® and Service ElectricSM customers.
Please enjoy 20 complimentary views of articles, photos, and videos during the next 30 days.
you have reached your 20 view limit
Access to News 12 is free for Optimum, Comcast®, Spectrum Networks® and Service ElectricSM customers.
Please login or create an account to continue enjoying News12.
Our sign-up page is undergoing maintenance and is not currently available. However, you will be given direct access to news12.com while we complete our upgrade.
When we are back up and running you will be prompted at that time to complete your sign in. Until then, enjoy the local news, weather, traffic and more that's "as local as local news gets."