Non-Opioid Treatment Approved by FDA for Opioid Withdrawal Symptoms

Kristen Coppock, MA, Editor
Published Online: Thursday, May 17th, 2018
The FDA has approved lofexidine hydrochloride (Lucemyra) for the mitigation of opioid withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults, aged 18 and older. While lofexidine hydrochloride may lessen the severity of withdrawal symptoms, it may not completely prevent them, and is only approved for treatment for up to 14 days, according to a press release issued by the FDA. Lofexidine hydrochloride is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing the condition.

“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, MD, in a statement. “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.”

Physical dependence to opioids is an expected physiological response to opioid use. Withdrawal symptoms, such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving, can occur after stopping or reducing the use of opioids, in an individual with physical dependence. Symptoms of opioid withdrawal occur in patients who have been using opioids appropriately as prescribed, and in patients with OUD.

For the full story about lofexidine hydrochloride, visit PharmacyTimes.com.

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