Achieve Life Sciences President and CMO, Dr. Cindy Jacobs, Speaks at FDA and NIH Smoking Cessation Public Meeting

Core Points - Achieve Life Sciences, Inc. is focused on the development and commercialization of cytisinicline for nicotine dependence treatment, with recent presentations at a joint FDA and NIH meeting aimed at advancing smoking cessation treatments [1][2] - Cytisinicline is currently the only late-stage nicotine dependence treatment, having completed two Phase 3 clinical trials with over 1,600 subjects, demonstrating strong safety and efficacy [2] - The FDA has not approved a new prescription smoking cessation treatment in nearly two decades, highlighting the need for innovation in this area [2] Company Overview - Achieve Life Sciences aims to address the global smoking health crisis, with approximately 29 million adults and 2.25 million middle and high school students in the U.S. smoking combustible cigarettes [4] - Tobacco use is 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. using e-cigarettes, with no FDA-approved treatments specifically for e-cigarette cessation [4] Product Details - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors, aiming to reduce nicotine cravings and satisfaction associated with nicotine products [5] - The drug has a revised formulation and dosing schedule compared to its predecessor, which had a complex 25-day titration regimen [2] - Achieve Life Sciences is preparing for a New Drug Application (NDA) filing and potential approval, following the completion of a long-term safety exposure study [2]