"We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms", said FDA Commissioner Scott Gottlieb, MD. "The lofexidine data demonstrate that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were significantly more likely to complete opioid withdrawal treatment".
The agency stressed that Lucemyra is not specifically approved for Opioid Use Disorder, and the drug's use shouldn't extend beyond 14 days. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. Since last April, when the Department of Health and Human Services announced its five-point plan for tackling the opioid crisis, just one novel pain treatment has gained FDA approval: Flexion Therapeutics' Zilretta (triamcinolone acetonide extended-release), a non-opioid option for osteoarthritis knee pain. It is not yet declared safe in children and adolescents up to the age of 17 years.
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.
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Patients' fear of experiencing withdrawal often hinders them from seeking treatment, and those who do seek help may relapse due to ongoing symptoms, Dr. Gottlieb added. Lucemyra was approved to treat withdrawal symptoms for up to two weeks.
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. Some patients experience mental side effects like anxiety and agitation, while others have physical ailments like vomiting and drug craving. At present the new drug has been granted Priority Review and Fast Track approval.
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.
An independent FDA advisory committee supported approving Lucemyra in March. 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.