Lucemyra (lofexidine hydrochloride) from US WorldMeds LLC is the first non-opioid treatment for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids.

For people looking to overcome addiction to opioids – and even patients who have been using opioids appropriately as prescribed - opioid withdrawal can be a difficult experience. Symptoms can include anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving.

Current practice for patients using prescribed opioid analgesics is a tapering off of the medication to reduce withdrawal symptoms. People addicted to opioids typically receive substitute opioid medicines that are gradually reduced and/or are transitioned to maintenance therapy—with FDA-approved medication-assisted treatment drugs such as methadone, buprenorphine or naltrexone. 

Both approaches, however, involve the continued use of opioids. The US Food and Drug Administration (FDA) previously granted Priority Review and Fast Track designations to Lucemyra (lofexidine hydrochloride), a new non-opioid treatment for withdrawal symptoms from US WorldMeds LLC that is designed to facilitate abrupt discontinuation of opioids in adults. The drug recently received FDA approval.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, which is believed to play a role in many of the symptoms of opioid withdrawal. It is approved for treatment up to 14 days. While not considered as a treatment for opioid use disorder (OUD), it can be used as part of a broader, long-term treatment plan for managing OUD. 

FDA is requiring 15 post-marketing studies, including both animal and human studies to support longer-term use (such as during a gradual opioid taper in pain patients discontinuing opioid analgesics) and use in children.

“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.”