The FDA today approved the first non-opioid treatment designed to help manage the symptoms of opioid withdrawal in adults.
The drug, Lucemyra, isn’t a treatment for opioid use disorder, the agency noted. Instead, it is meant to be used as part of a broader plan to help adults manage their symptoms when they stop using opioids.
“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms,” FDA commissioner Dr. Scott Gottlieb said in prepared remarks.
Lucemyra, made by U.S. WorldMeds, is an oral, selective alpha 2-adrenergic receptor agonist that lessens the brain’s release of norepinephrine.
“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,” he added.
Symptoms of opioid withdrawal, which include anxiety, vomiting, nausea and cravings, can occur in patients who are using opioids appropriately (as prescribed by doctors) and by people abusing opioids. Many therapies designed to treat opioid use disorder require that patients first endure withdrawal.
“Today’s approval represents the first FDA-approved non-opioid treatment for the management of opioid withdrawal symptoms and provides a new option that allows providers to work with patients to select the treatment best suited to an individual’s needs,” said Dr. Sharon Hertz, director of the division of anesthesia, analgesia and addiction products in the FDA’s Center for Drug Evaluation and Research.
With this approval, the FDA said it will require the company to conduct 15 post-marketing studies to assess the long-term safety of the product and its use in children. The drug is currently only approved for a 14-day treatment period.
The agency explained that pediatric studies for Lucemyra will include newborns with neonatal opioid withdrawal, as well as children experiencing opioid withdrawal after stopping medically-prescribed opioids.