FDA Approves First Non-Opioid For Management Of Opioid Withdrawal Symptoms

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

Lucemyra is not an opioid drug and is not a treatment for opioid use disorder (sometimes known as opioid addiction).

FDA Commissioner Scott Gottlieb, M.D.in his statement said, "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..."

The NIH says these symptoms aren't directly life-threatening, but they can drive the patient back to opioid use - often overdosing after experiencing withdrawal.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said.

Lofexidine Hydrochloride, also referred to as the brand name Lucemyra, is now FDA Approved.

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Lucemyra is an oral medication that reduces the release of norepinephrine, which is believed to be associated with opioid withdrawal symptoms. Regulatory approval was based on two randomized, double-blind, placebo-controlled clinical trials, an open-label study, and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone, according to the company release. Results showed that SOWS-Gossop scores were lower in patients who are treated with Lucemyra compared to placebo.

The FDA said its decision to approve the drug was supported by data gathered from two clinical studies involving 866 clinically opioid-dependent adults, following abrupt discontinuation of use.

New medication targets symptoms experienced when reducing or stopping opioids due to physical dependence. These include animal and in-human studies to examine long-term use of Lucemyra, potentially during a gradual opioid dose-reduction process rather than sudden removal. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain. These side effects incorporate feeling wiped out, stomach issues, muscle fits/jerking, feeling of coldness, heart beating, strong pressure, a throbbing painfulness, yawning, runny eyes and a sleeping disorder/issues dozing.

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

Patients with chronic pain can attend the FDA's "Patient-Focused Drug Development for Chronic Pain" meeting on July 9 from 10 a.m.to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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