The FDA approved Lucemyra, the first nonopioid treatment for adults managing opioid withdrawal symptoms, the agency announced May 16.
Lucemyra is an oral medication that reduces the release of norepinephrine, which is believed to be associated with opioid withdrawal symptoms. Although Lucemyra may lessen the severity of withdrawal symptoms, it may not entirely prevent them and is only approved for treatment for up to two weeks, the agency stated.
The drug is not for treating opioid use disorder but can be used as part of a long-term plan for managing it, the agency added.
"We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms," said FDA Commissioner Scott Gottlieb, MD. "We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction."
Patients' fear of experiencing withdrawal often hinders them from seeking treatment, and those who do seek help may relapse due to ongoing symptoms, Dr. Gottlieb added.
"The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments," Dr. Gottlieb said.