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FDA approves first non-opioid drug for treating opioid withdrawal symptoms

FDA approves first non-opioid drug for treating opioid withdrawal symptoms

Clinical investigations will be required to assess the wellbeing of Lucemyra in clinical circumstances where utilize could be relied upon to surpass the most extreme 14-day treatment period for which the item is as of now affirmed, for example, steady opioid decrease; to accumulate extra security information on the impacts of lofexidine on the liver; and to additionally describe the consequences for circulatory strain after lofexidine is halted.

In a blog post published on Monday, Scott Gottlieb, the Food and Drug Administration commissioner, said the FDA is listening to opioid-related concerns from patients with chronic pain.

In late-stage testing, patients physically dependent on opioids who abruptly quit taking them reported less severe withdrawal symptoms when taking Lucemyra compared to placebo.

"Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction", said Marc Fishman, MD, medical director, Maryland Treatment Centers and assistant professor, Johns Hopkins University School of Medicine.

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

The non-opioid tablets can be used for up to two weeks. The drugs are notoriously addictive, with withdrawal symptoms including extreme nausea, vomiting, and anxiety. Physical dependence to opioids is an expected physiological response to opioid use.

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Withdrawal is typically managed with the substitution of another opioid, like buprenorphine or methadone, which is then gradually reduced.

The FDA granted this application both priority review and fast track designations. 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.

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. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms.

US WorldMeds anticipates that Lucemyra's use will go beyond those who are full-fledged addicts. SOWS-Gossop scores were brought down for patients treated with Lucemyra contrasted with fake treatment, and more patients finished the treatment time of the investigations in the Lucemyra amass contrasted with fake treatment.

Side effects included low blood pressure, dizziness, sleepiness, slow heart rate and, in a few people, fainting. Lucemyra was additionally connected with a couple of instances of syncope (blacking out).

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

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