Smoking Cessation Aid Cytisinicline Could Soon Get FDA Approval
More than two-thirds of American smokers say they want to quit. However, besides nicotine replacement therapies, there are at present only two smoking cessation drugs without nicotine that are authorized for marketing by the Food and Drug Administration. This could change soon, as the pharmaceutical firm Achieve Life Sciences submitted to the FDA a new drug application last week for its prescription medicine, cytisinicline, also known as cytisine. The agency will review the medication's efficacy, safety, and tolerability profile based on evidence from two large, placebo-controlled Phase 3 clinical trials.
The substance is a naturally occurring plant-based alkaloid that selectively binds to nicotinic receptors in the brain. In turn, this can help alleviate nicotine cravings and reduce withdrawal symptoms, among smokers of combustible cigarettes as well as e-cigarettes (vaping).
Cytisinicline has been used as a smoking cessation product for decades in some Central and Eastern European countries. It was approved by the British Medicines and Healthcare products Regulatory Agency in March 2019, though only available commercially in the United Kingdom since January 2024. Cytisinicline hasn't yet been approved by the European Medicines Agency.
The Journal of the American Medical Association Internal Medicine published results from one of two Phase 3 trials evaluating cytisinicline for smoking cessation. The authors' conclusions reaffirmed cytisinicline's efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks. Additionally, a study published in 2024 suggested cytisinicline could be effective for e-cigarette cessation.
Owing to its mechanism of action as a way to reduce nicotine dependence, it's possible that cytisinicline could be beneficial for individuals using nicotine pouches who wish to stop, though this hasn't yet been examined specifically.
Based on a technology assessment of the benefits and costs of cytisinicline, the British cost-effectiveness watchdog, the National Institute for Health and Care Excellence, recommended earlier this year adding the drug to the National Health Service as a treatment option for smoking cessation.
And this week, the American Institute for Clinical and Economic Review announced it is conducting an evidence review to assess the clinical effectiveness of cytisinicline together with behavior support. The evaluation will include comparisons with other existing smoking cessation products.
Smoking is the leading cause of preventable death in the U.S. Cigarette smoking is responsible for more than 480,000 deaths annually in the U.S. The
major causes of death associated with smoking include cardiovascular diseases such as strokes and heart attacks; cancers, among which lung, pancreatic, esophageal, bladder, colorectal and renal; and pulmonary conditions such as chronic obstructive lung disease, pneumonia and bronchitis.
Last October, the FDA and the National Institutes of Health convened a public meeting to address the urgency for developing novel smoking cessation products to assist individuals of all ages, including underserved and vulnerable populations, to stop smoking. There is unmet need in this space, reflected in the fact that of the 15 million who tried to quit smoking in 2022, five in six failed, according to STAT News. Experts cite a lack of sufficiently effective smoking cessation drugs.
Should cytisinicline become available in the U.S. it could represent an important option for those who wish to quit their nicotine habit. At the same time, it will continue to be critical for healthcare providers and public health authorities to raise awareness around the importance of smoking cessation and prevention, provide behavior support (counseling) and offer treatment alternatives people can use to quit.
The U.S. has made real progress since the 1960s in reducing cigarette smoking, mainly through effective public health campaigns. Yet there's still a lot more work to do as roughly 29 million adults smoke combustible cigarettes and approximately 17 million use e-cigarettes.
But under the Trump administration the Department of Health and Human Services has cut funding for smoking cessation and prevention programs, as well as eliminated the Centers for Disease Control and Prevention's Office on Smoking and Health. While the CDC says it will continue to provide resources for those who wish to quit smoking while conducting ongoing surveillance, experts warn that cuts in services could limit access, which could then result in a resurgence in smoking rates.
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