Federal regulators have approved the first nonopioid treatment to ease withdrawal from quitting addictive opioids.
“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.
