FDA approves 1st nonopioid drug to ease withdrawal symptomsMay 16, 2018 11:06pm

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

Page 1 of 1

More Stories Like This

US raises concerns about illnesses tied to synthetic potFederal health officials are urging states to regulate marijuana oil extracts after investigating a rash of illnesses tied to the products in Utah
Tribes ask Interior secretary for help with meth addictionLeaders of a tribal executive board in Montana are asking U.S. Interior Secretary Ryan Zinke for help battling meth addiction in their community
In this May 16, 2018 photo, Cathy Jordan, right, who has been suffering from ALS since 1987, looks on after completing testimony in Tallahassee, Fla., that would declare a smoking ban on medical marijuana unconstitutional in Florida. A Florida judge on Friday, May 25, 2018, ruled that the ban is unconstitutional. (AP Photo/Joe Reedy)
Florida ban on smokable medical pot ruled unconstitutional
Global Cataract Devices Market to Benefit from an Increase in Treatment Awareness Programs | Technavio
For CEOs, $11.7 million a year is just middle of the packThe typical chief executive at the biggest U.S. companies got an 8.5 percent raise last year and made $11.7 million in salary, stock and other compensation
Scientists find opioids in Puget Sound musselsScientists who track pollution have discovered traces of the pain reliever oxycodone in some Puget Sound mussels
This component is currently unavailable.

Related Searches

Related Searches