Achieve Life Sciences Announces Publication in Thorax of Data Demonstrating Cytisinicline's Potential Efficacy and Tolerability for Smoking Cessation in Individuals with COPD

Core Insights - Achieve Life Sciences announced new data showing that cytisinicline significantly improves smoking quit rates in adults with and without chronic obstructive pulmonary disease (COPD) compared to placebo [1][2][3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence treatment [6] - The FDA has accepted Achieve's New Drug Application for cytisinicline, with a target action date of June 20, 2026 [5][6] Clinical Data - The publication in Thorax presents a post hoc analysis of over 1,600 participants from the ORCA-2 and ORCA-3 trials, highlighting the efficacy and safety of cytisinicline in individuals with self-reported COPD [2][3] - Cytisinicline demonstrated statistically significant increases in continuous smoking abstinence for both COPD and non-COPD subgroups, with quit rates for COPD participants comparable to those without COPD [3] Health Impact - Nearly 16 million U.S. adults have been diagnosed with COPD, with 6 million currently smoking; quitting smoking is crucial for improving health outcomes in this population [4] - Approximately 80% of COPD deaths are attributed to smoking, emphasizing the need for effective cessation tools like cytisinicline [4] Future Developments - Achieve has completed a Phase 2 trial for cytisinicline in vaping cessation and has received Breakthrough Therapy designation from the FDA for this indication [5][8]