Achieve Life Sciences(US:ACHV) Globenewswireยท2025-07-24 12:30Company 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 submitted its New Drug Application to the FDA for cytisinicline in June 2025, based on two completed Phase 3 studies and a fully enrolled open-label safety study [3] - Achieve has also completed a Phase 2 study for vaping cessation and had a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [3] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [6] - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, responsible for over eight million deaths worldwide annually [4] - There are about 17 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] Market Context - The smoking and vaping cessation market is significant, with a large population of nicotine-dependent individuals and a lack of effective treatments currently available [5] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA, indicating its potential importance in addressing nicotine dependence [5] - The company is positioned to capitalize on the growing awareness and need for effective smoking cessation therapies as public health initiatives continue to combat tobacco use [4][5]