The approval of cytisine, a plant-based drug used for smoking cessation in several countries, is delayed in the U.S. due to the FDA’s request for additional safety data. Experts warn this could prevent thousands of Americans from quitting smoking.
Cytisine has been available in countries like Canada and the U.K. for years and is known to be more effective than nicotine patches and gum. It also causes fewer side effects than varenicline, a commonly used smoking cessation drug.
The FDA’s request has delayed cytisine’s potential U.S. approval by at least a year.
According to a recent study, if cytisine were available in the U.S., it could help around 71,000 people quit smoking in just one year, potentially adding over 500,000 life-years by reducing smoking-related deaths.
The delay could reduce these gains by 10,000 life-years annually.
Cytisine works by targeting nicotine receptors in the brain, reducing cravings and the satisfaction from smoking. It’s been shown to be more effective than current nicotine replacement therapies and has milder withdrawal symptoms than varenicline.
Research from the University of Oxford supports cytisine’s potential to help smokers quit, and ongoing clinical trials in the U.S. have shown positive early results. Despite the promising data, the FDA’s demand for further safety information has pushed back the drug’s approval.
Public health experts emphasize the need for timely approval, given the high relapse rates among smokers and the limitations of existing treatments. Delays, they argue, could result in significant public health setbacks.
