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American Focus > Blog > Health and Wellness > Smoking Cessation Aid Cytisinicline Could Soon Get FDA Approval
Health and Wellness

Smoking Cessation Aid Cytisinicline Could Soon Get FDA Approval

Last updated: July 5, 2025 3:48 pm
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Smoking Cessation Aid Cytisinicline Could Soon Get FDA Approval
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Achieve Life Sciences has recently submitted a new drug application to the FDA for cytisinicline, a non-nicotine smoking cessation drug. This plant-based alkaloid selectively binds to nicotinic receptors in the brain, helping to reduce nicotine cravings and withdrawal symptoms. While already approved in the UK, cytisinicline is now under review by the FDA based on evidence from Phase 3 clinical trials.

Studies have shown that cytisinicline is effective for smoking cessation in both combustible cigarette smokers and e-cigarette users. The drug has also been recommended for inclusion in the National Health Service in the UK and is currently undergoing evaluation by the American Institute for Clinical and Economic Review.

With smoking being the leading cause of preventable death in the US, the need for effective smoking cessation products is crucial. Cytisinicline could provide a valuable option for individuals looking to quit smoking, especially as current cessation drugs have shown limited effectiveness.

While progress has been made in reducing smoking rates in the US, there is still a significant number of adults who smoke. However, funding cuts for smoking cessation programs under the previous administration have raised concerns about access to these vital resources.

As efforts continue to address smoking cessation and prevention, the potential approval of cytisinicline in the US could offer a new tool in the fight against smoking-related illnesses. It is essential for healthcare providers and public health authorities to promote awareness and provide support for those looking to quit smoking.

See also  STAT Health News: Bulk milk testing for bird flu, UnitedHealth takes on critics
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