Core Insights - Achieve Life Sciences announced significant results from the ORCA-3 trial, demonstrating that cytisinicline effectively aids in smoking cessation by increasing quitting rates and reducing nicotine cravings compared to placebo [1][2][4] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence and smoking cessation [7][8] - The company plans to submit a New Drug Application (NDA) for cytisinicline to the FDA in June 2025 [1][5] Clinical Trial Details - The ORCA-3 trial involved 792 U.S. adults, assessing the efficacy of cytisinicline over 6 and 12 weeks, with results published in JAMA Internal Medicine [1][6] - Participants had an average age of 53 years, smoked a median of 20 cigarettes per day, and had a median smoking history of 36 years [3][6] - Cytisinicline was administered at a dosage of 3mg three times daily, with behavioral support provided throughout the trial [6] Efficacy and Tolerability - Cytisinicline showed a significant increase in the odds of smoking cessation and a reduction in nicotine cravings, leading to decreased nicotine intake among participants [4][5] - The drug was well tolerated, attributed to its selective binding to nicotine receptors with limited off-target effects [2][4] Market Context - Tobacco use is the leading cause of preventable death, with over 8 million deaths globally and nearly half a million in the U.S. annually [9] - There is a critical need for effective smoking cessation treatments, as current options are limited [5][9]

Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [3] - The company has successfully completed two Phase 3 studies for smoking cessation and one Phase 2 study for vaping cessation, with plans to submit a new drug application in Q2 2025 [3][6] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aimed at reducing nicotine cravings and the satisfaction associated with nicotine products [6] - Approximately 29 million adults smoke combustible cigarettes in the U.S., with tobacco use being the leading cause of preventable death, responsible for over 8 million deaths globally and nearly half a million in the U.S. annually [4] - There are over 11 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [5] Upcoming Events - Achieve Life Sciences will present at the Barclays 27th Annual Global Healthcare Conference from March 11-13, 2025, with CEO Rick Stewart scheduled to present on March 12, 2025 [1][2]