Achieve Life Sciences to Present New Data at the 2025 ATS International Conference Demonstrating that Cytisinicline Reduced Cravings and Nicotine Intake

Core Insights - Achieve Life Sciences is presenting additional analyses from its Phase 3 ORCA-3 study on cytisinicline at the 2025 ATS International Conference, emphasizing its dual mechanism of action in treating nicotine dependence [1][8] - Cytisinicline has shown significant efficacy in reducing nicotine cravings and intake, even among smokers who do not completely quit, indicating its potential as a therapeutic option for smoking cessation [3][4] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence and smoking cessation, having completed two Phase 3 studies and one Phase 2 study for vaping cessation [7] - The company plans to submit a New Drug Application for cytisinicline in June 2025, aiming to address the smoking health epidemic affecting millions [6][7] Clinical Findings - The ORCA-3 study demonstrated a significant reduction in craving scores (p=0.0001) and serum cotinine levels among participants treated with cytisinicline compared to placebo, with a reduction equivalent to nearly four times more in cotinine levels [4][5] - Cytisinicline's dual action as a selective partial agonist and antagonist at the nicotinic acetylcholine receptor may help smokers reduce their nicotine intake while on the path to quitting [3][5] Market Context - There are approximately 29 million adult smokers in the U.S., with smoking being the leading cause of preventable death, highlighting the critical need for effective cessation treatments [9] - Cytisinicline has received Breakthrough Therapy designation from the FDA, indicating its potential to address the urgent need for effective nicotine cessation therapies [10][11]