Cytisinicline Overview - Cytisinicline represents a potential new treatment for nicotine dependence in nearly 20 years, targeting an addressable market of up to 50 million Americans who use tobacco[7] - The FDA's PDUFA date for cytisinicline for smoking cessation is expected on June 20, 2026[9] - Nicotine dependence is a significant public health crisis, costing billions of dollars[7] Clinical Trial Results - Smoking cessation trials (ORCA-2 and ORCA-3) demonstrated robust efficacy, excellent tolerability, and significant craving reduction[30] - In 12-week cytisinicline treatment trials, quit rates reached 32.6% compared to 7% with placebo, yielding an odds ratio of 6.3 (p<0.0001)[31] - In 6-week cytisinicline treatment trials, quit rates reached 25.3% compared to 4.4% with placebo, yielding an odds ratio of 8.0 (p<0.0001)[31] - Cytisinicline shows a more favorable adverse event profile compared to Varenicline (Chantix®), with lower rates of nausea (6.2% vs 30%), insomnia (10.8% vs 18%), abnormal dreams (7.7% vs 13%), and headache (8.1% vs 15%)[37] Market and Commercial Strategy - Over $600 billion is spent annually in the U S on smoking-related health care costs[14] - Approximately 29 million U S smokers have few treatment options[15] - The company estimates an $11 billion Rx opportunity in the smoking cessation market[57]