FDA NewsPerspective

FDA approves first non-opioid agent for regulating opioid withdrawal symptoms

Scott Gottlieb
Scott Gottlieb

Today the FDA announced its approval of Lucemyra, the first non-opioid treatment for lessening the severity of opioid withdrawal symptoms, such as anxiety, agitation, sleep issues, nausea and vomiting, in adults, according to a press release.

Lucemyra (lofexidine hydrochloride) helps patients discontinue opioids quickly and is intended to be used for a maximum of 14 days, according to the FDA. The FDA noted that lofexidine hydrochloride does not completely prevent withdrawal symptoms.

“[The FDA is] developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms,” Scott Gottlieb, MD, commissioner of the FDA, said in the release. “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 approval of lofexidine hydrochloride, an oral, selective alpha 2-adrenergic receptor agonist, was based on the results of two randomized, double-blind, placebo-controlled clinical trials. The trials involved 866 adults who were opioid-dependent and undergoing abrupt opioid discontinuation. The researchers assessed participants’ withdrawal severity using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop). The found that patients receiving lofexidine hydrochloride had lower withdrawal severity scores, compared with those receiving placebo.

Today the FDA announced its approval of Lucemyra, the first non-opioid treatment for lessening the severity of opioid withdrawal symptoms, such as anxiety, agitation, sleep issues, nausea and vomiting, in adults.
Photo credit: Shutterstock

Hypotension, bradycardia, somnolence, sedation and dizziness were the most common adverse events associated with lofexidine hydrochloride. A small number of syncope cases associated with lofexidine hydrochloride were also observed. The FDA noted that patients may experience a pronounced surge in BP when discontinuing lofexidine hydrochloride.

Lofexidine hydrochloride has not been confirmed to be safe or effective in children or adolescents younger than 17 years of age, according to the FDA.

The FDA reported that it is requiring 15 postmarketing human and animal studies to support lofexidine hydrochloride for longer-term use, use in children and additional safety data.

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

Scott Gottlieb
Scott Gottlieb

Today the FDA announced its approval of Lucemyra, the first non-opioid treatment for lessening the severity of opioid withdrawal symptoms, such as anxiety, agitation, sleep issues, nausea and vomiting, in adults, according to a press release.

Lucemyra (lofexidine hydrochloride) helps patients discontinue opioids quickly and is intended to be used for a maximum of 14 days, according to the FDA. The FDA noted that lofexidine hydrochloride does not completely prevent withdrawal symptoms.

“[The FDA is] developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms,” Scott Gottlieb, MD, commissioner of the FDA, said in the release. “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 approval of lofexidine hydrochloride, an oral, selective alpha 2-adrenergic receptor agonist, was based on the results of two randomized, double-blind, placebo-controlled clinical trials. The trials involved 866 adults who were opioid-dependent and undergoing abrupt opioid discontinuation. The researchers assessed participants’ withdrawal severity using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop). The found that patients receiving lofexidine hydrochloride had lower withdrawal severity scores, compared with those receiving placebo.

Today the FDA announced its approval of Lucemyra, the first non-opioid treatment for lessening the severity of opioid withdrawal symptoms, such as anxiety, agitation, sleep issues, nausea and vomiting, in adults.
Photo credit: Shutterstock

Hypotension, bradycardia, somnolence, sedation and dizziness were the most common adverse events associated with lofexidine hydrochloride. A small number of syncope cases associated with lofexidine hydrochloride were also observed. The FDA noted that patients may experience a pronounced surge in BP when discontinuing lofexidine hydrochloride.

Lofexidine hydrochloride has not been confirmed to be safe or effective in children or adolescents younger than 17 years of age, according to the FDA.

The FDA reported that it is requiring 15 postmarketing human and animal studies to support lofexidine hydrochloride for longer-term use, use in children and additional safety data.

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

    Perspective

    Adam Bisaga

    This is certainly welcomed news. Even though there are several medications that can help relieve opioid withdrawal symptoms, none of them is FDA-approved for that indication. Having a medication specifically approved for managing opioid withdrawal should help to recognize that a medical intervention should be used as a strategy to manage patients with opioid dependence.

    Treating opioid withdrawal by itself is not recognized as a strategy to treat opioid dependence, but Lucemyra may allow patients to successfully initiate relapse prevention treatment with other FDA-approved medications such as buprenorphine and extended-release naltrexone. Moreover, Lucemyra should be very useful in helping patients chronically treated with opioids for pain to discontinue them, when clinically indicated.

    • Adam Bisaga, MD
    • Healio Psychiatry Peer Perspective Board Member
      Professor of Psychiatry
      Columbia University

    Disclosures: Bisaga reports no relevant financial disclosures.

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