Federal regulators on Wednesday approved the first nonopioid treatment to ease withdrawal via quitting addictive opioids.
The U.S. Food as well as 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 as well as prescription painkillers.
The pill was approved to treat adults for up to two weeks for common withdrawal symptoms like vomiting, diarrhea, muscle pain as well as agitation. the item will be not an addiction medicine yet 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 via opioid addiction via 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 as well as, in a few people, fainting.
The FDA will be requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens as well as newborns of opioid-addicted mothers as well as for possible longer-term use in people tapering off opioids.
Privately held US WorldMeds said the item had not yet set a cost for Lucemyra.