Cytisine, known for its efficacy in tobacco smoking cessation, is an over-the-counter medicine with a rich 60-year history in Europe. While this natural compound is not yet available in the United States, that might be changing soon.
With its historical roots in Eastern Europe and Asia, Cytisine first surfaced as Tabex® in the 1960s and later as Desmoxan® in Poland in 2017. Meanwhile, our neighbors to the north can already access the pharmaceutical version of cytisine as Cravv® in Canada, available over the counter as a natural health product.
Professor Lisa Fucito from the Yale School of Medicine highlights the conundrum: “The challenge in the U.S. is that you need a pharma company behind a med” (via Slate Magazine). Cytisine, also known as cytisinicline, is a chemical naturally synthesized by plants in the Fabacea Family, rendering it impossible to patent. This lack of patentability poses challenges as there are limited incentives for any company to navigate cytisine through the stringent FDA approval process. Without such backing, cytisine has remained off American shelves.
The potential of cytisine is undeniable. Not only is its synthesis cost-effective, but it also boasts an impressive safety profile, with clinical trials reporting no serious concerns.
Hope emerged in a recent JAMA phase 3 clinical trial funded by Achieve Life Sciences Inc. Smoking participants on cytisinicline experienced a rapid and sustained decline in cravings and smoking urges within the initial six weeks of treatment. Further bolstering the alkaloid compound, the clinical trial found that, during the 12-week treatment period, 32.6% of participants receiving cytisinicline were abstinent during weeks 9 to 12, compared to only 7.0% with a placebo. Impressively, the cytisinicline treatment group had six times higher odds of successfully quitting smoking.
Researchers from the Centro Nacional de Intoxicaciones at Buenos Aires included this and other clinical trials in their recent systematic review and meta-analysis. Published in the journal Addiction in December 2023, their analysis discovered that across a dozen clinical trials, individuals taking cytisine had a 2.25 times higher chance of successfully quitting smoking. The researchers also report that cytisine outperforms nicotine replacement therapy.
Experts predict that FDA approval for cytisinicline may be close at hand. According to Dr. James Davis, MD, Associate Professor of Medicine and Medical Director for Duke Center for Smoking Cessation, “it is likely that we may see a new smoking cessation medication available on the market in the next year or two – Cytisinicline – for use in patients smoking cigarettes,” (via DukeUNCTTS).
As the story of cytisine unfolds, a natural solution for smoking cessation beckons, offering a glimpse of a future where breaking free from tobacco addiction may be more attainable than ever.
Sources: Slate, Addiction, EurekAlert!, JAMA, Duke UNCTTS