FDA approves first non-opioid treatment for withdrawals

WASHINGTON, D.C. – In a promising move in the ongoing battle against the nation’s opioid epidemic, federal authorities approved a non-opioid based drug to combat symptoms of withdrawal.

According to the U.S. Food and Drug Administration, Lucemyra (lofexidine hydrochloride) was approved on May 16, 2018. The drug can work to lessen the severity of opioid withdrawal symptoms. However, it may not completely prevent them.

The FDA said the approval is an encouraging step in the development of safe and effective treatments for opioid use disorders.

“As part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids,” said FDA Commissioner Scott Gottlieb, M.D. “We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms. 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. 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.”

In patients with opioid use disorder, withdrawal is typically managed through an FDA-approved therapy involving medication-assisted drug treatments using methadone, buprenorphine or naltrexone.

“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 Sharon Hertz, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research.

The FDA granted the approval of Lucemyra to US WorldMeds LLC.