FDA Approves First Nonopioid Treatment for Opioid Withdrawal Symptoms

by Noah Mcgee May 18, 2018, 9:28
FDA Approves First Nonopioid Treatment for Opioid Withdrawal Symptoms

"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 an agency release.

Although researchers are confident that Lucemyra will help some patients manage symptoms, there are some concerns.

This is the first nonopioid treatment to ease withdrawal from quitting the use of addictive opioids. And those who seek assistance may relapse due to continued withdrawal symptoms.

Patients who go off opioid painkillers face excruciating withdrawal symptoms such as anxiety, nausea, vomiting, insomnia, muscle aches and more.

These are seen in individuals who have physical dependence on opioids and also occurs if the dose is reduced.

In patients utilizing opioid analgesics fittingly as endorsed, opioid withdrawal is regularly overseen by a moderate decrease of the prescription, which is planned to dodge or reduce the impacts of withdrawal while enabling the body to adjust to not having the opioid.

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Recommended dosing for lofexidine is three 0.18 mg tablets taken orally four times daily, when patients are experiencing peak withdrawal symptoms (generally 5 to 7 days following last use of opioids, the company said in a news release).

Because Lucemyra can make withdrawal process easier for patients, National Institute on Drug Abuse Director Nora Volkow, M.D., argues it could boost wider use of Vivitrol, which differentiates itself from methadone and buprenorphine, two other addiction treatments that belong to the opioid family. It is not approved as a treatment for opioid use disorder.

Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. In two randomized, double-blind, placebo-controlled trials, 866 adult patients demonstrated the benefits and safety of the drug. SOWS-Gossop scores were lower for patients treated with Lucemyra compared to placebo, and more patients completed the treatment period of the studies in the Lucemyra group compared to placebo.

Potential side effects include low blood pressure, slow heart rate, dizziness, sleepiness, fainting and dry mouth. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger.

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