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FDA Commissioner Says FDA Will Listen to Chronic Pain Patients About Opioids

FDA approves Lucemyra to treat symptoms of opioid withdrawal and help patients overcome addiction

The FDA approved the first non-opioid medication to treat opioid withdrawal in adults, in order to "facilitate abrupt discontinuation of opioids in adults", the agency said Wednesday.

Used for more than two decades in the United Kingdom, the oral drug isn't meant to treat opioid addiction or curb drug cravings.

The drug is not for treating opioid use disorder but can be used as part of a long-term plan for managing it, the agency added.

Lucemyra is usually administered in three 0.18 mg tablets taken orally four times daily at five- to six-hour intervals during the period of peak withdrawal symptoms (generally five to seven days following last use of opioids); total treatment may continue for up to 14 days. Less common reactions could include fainting and abnormal heart rhythms.

"Lucemyra offers new hope to people who want to discontinue opioid use and are struggling with the agonizing symptoms of opioid withdrawal", said P. Breckinridge Jones, chief executive officer and founder of US WorldMeds.

Lofexidine is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine.

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

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

While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency.

Lucemyra suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal.

Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments". The drug has not been evaluated in people under age 17, the FDA said.

The FDA granted Lucemyra the go-ahead after previous priority review and fast track designations, and it comes after an independent scientific panel voted 11-1 in favor of its approval.

Privately held US WorldMeds said it had not yet set a price for Lucemyra.

The FDA said it would be requiring 15 postmarketing studies on lofexidine, "including both animal and human studies" to examine whether the drug could also be used in gradual opioid tapers and in pediatric patients, and also to better understand potential effects on blood pressure and hepatic function. 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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