US FDA grants cytisine therapy approval: can be used to quit nicotine e-cigarette addiction

US FDA grants cytisine therapy approval: can be used to quit nicotine e-cigarette addiction

The U.S. Food and Drug Administration (FDA) has granted Cytisinicline a breakthrough therapy designation for quitting nicotine e-cigarettes. It is reported that if the drug is finally approved, it will become the first drug specifically used to quit nicotine e-cigarettes. It is worth noting that cytisinicline is still an experimental product and has not yet been approved by the FDA for any use in the United States.

According to investing on July 31, the U.S. Food and Drug Administration (FDA) has granted Cytisinicline a breakthrough therapy designation for quitting nicotine e-cigarettes. This drug comes from Achieve Life Sciences, a professional pharmaceutical company in the United States. It is reported that if the drug is finally approved, it will become the first drug specifically used to quit nicotine e-cigarettes. It is worth noting that cytisinicline is still an experimental product and has not yet been approved by the FDA for any use in the United States.

Cytisinicline is a plant alkaloid with high binding affinity to nicotinic acetylcholine receptors. It helps treat nicotine addiction caused by smoking and e-cigarette withdrawal by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms and reducing the rewards and satisfaction associated with nicotine products.

It is understood that the company's ORCA-V1 Phase II clinical trial compared the effects of cytisine and placebo in 160 adult e-cigarette users. The experiment showed that participants treated with cytisine were 2.6 times more likely to successfully quit smoking than those using placebo. Achieve plans to hold a Phase II end-of-phase meeting with the FDA multidisciplinary team before the end of this year to discuss the next steps.

Data show that more than 11 million adults in the United States use e-cigarettes, and about 2.1 million middle school students use e-cigarettes. At present, the FDA has not approved any treatment specifically for helping to quit nicotine e-cigarettes.