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.
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