FDA Grants Breakthrough Therapy Designation for Cytisinicline to Quit Nicotine E-Cigarettes

Regulations by 2FIRSTS.ai

Aug.01.2024

FDA Grants Breakthrough Therapy Designation for Cytisinicline to Quit Nicotine E-Cigarettes

The FDA grants breakthrough designation for Cytisinicline as a therapy to quit nicotine e-cigarettes from Achieve Life Sciences.

According to investing7's report on July 31, the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for Cytisinicline, a treatment for nicotine e-cigarette cessation. This medication is developed by the American pharmaceutical company Achieve Life Sciences. If approved, it would be the first drug specifically designed for nicotine e-cigarette cessation. It is important to note that Cytisinicline is currently an experimental product and has not received any approval for use by the FDA in the United States.

Golden Chrysanthemum Alkaloid is a plant-based alkaloid with high affinity for binding to nicotine acetylcholine receptors. By interacting with nicotine receptors in the brain, it reduces the severity of withdrawal symptoms and decreases the reward and satisfaction associated with nicotine products, aiding in the treatment of nicotine addiction resulting from smoking and e-cigarette cessation.

According to sources, the company's ORCA-V1 phase II clinical trial compared the effects of lobeline and a placebo on 160 adult e-cigarette users. The experiment showed that participants treated with lobeline were 2.6 times more likely to successfully quit smoking compared to those using the placebo. Achieve Corporation plans to hold a phase II final meeting with the FDA's multidisciplinary team by the end of this year to discuss the next steps.

Data shows that over 11 million adults in the United States use e-cigarettes, with approximately 2.1 million middle and high school students also using them. Currently, the FDA has not approved any specific treatment methods to help individuals quit nicotine e-cigarettes.

References:

[1] FDA concede status de avanço ao medicamento para parar de vape da Achieve

Also Read:

[1] FDA-Authorized VUSE E-Cigarettes: Diverse Nicotine Levels in Tobacco Flavors

[2] First FDA-Approved Plant-Based Drug "Cytisinicline" Helps Smokers Quit E-Cigarettes

[3] UK Approves Sale of Promising Smoking Cessation Medication, Cytisine

#North America #United States #Regulation #FDA #Nicotine-free e-cigarettes

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