FDA approves first non-opioid to treat withdrawal symptoms in adults

FDA approves first non-opioid to treat withdrawal symptoms in adults

FDA on Wednesday (May 16) approved US WorldMeds LLC's Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal.

Developed under private company US WorldMeds, Lucemyra works by diminishing the release of norepinephrine, a neurotransmitter that relays feelings of pain and affects withdrawal symptoms, research suggests. The agency noted that the treatment may not completely prevent withdrawal symptoms (eg, anxiety, agitation, sleep problems, muscle aches, sweating, nausea, diarrhea, drug craving), and is only approved for use up to 14 days.

"We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction", FDA Commissioner Scott Gottlieb said in a news release.

Gottlieb said fear of withdrawal often discourages those with a physical dependence from seeking treatment, and the potentially intense symptoms often contribute to relapses.

Trump seeks 'very meaningful' summit in Singapore with N Korea
It can be said that Trump's decision to choose a third-party country by attaching importance to neutrality was wise. China is now North Korea's biggest trade partner and the peninsula nation relies heavily on China for its economy.

As a major aspect of the U.S. Bureau of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis, the FDA stays focused on tending to the national emergency of opioid compulsion on all fronts, with a critical spotlight on diminishing presentation to opioids and averting new enslavement; supporting the treatment of those with opioid utilize scatter; cultivating the advancement of novel torment treatment treatments and opioids more impervious to manhandle and abuse; and making a move against the individuals who add to the unlawful importation and offer of opioid items. It is not approved as a treatment for opioid use disorder.

Studies in pediatric patients will be conducted on newborns with neonatal opioid withdrawal and studies of various age groups of children with opioid withdrawal related to stopping medical-prescribed opioid drugs. Trial participants treated experienced less severe withdrawal symptoms compared to placebo and were significantly more likely to complete a seven-day opioid discontinuation treatment. Less common reactions could include fainting and abnormal heart rhythms. When Lucemyra is stopped, patients can experience a marked increase in blood pressure.

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 independent FDA advisory committee supported approving Lucemyra in March. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA. 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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