Achieve Life Sciences Presents Data at SRNT Demonstrating Successful Cessation in Smokers with Extensive Prior Treatment Exposure; and on Participant Experience in the ORCA-OL Study

Core Insights - Achieve Life Sciences, Inc. announced new data indicating that cytisinicline is effective in helping individuals quit smoking, including those who have previously failed with other cessation medications and regardless of their quit attempt history [1][4][3] Group 1: Clinical Data and Efficacy - A pooled Phase 3 analysis involving over 1,600 participants demonstrated high quit rates with cytisinicline after 6 and 12 weeks of treatment, showing effectiveness across various prior treatment histories [1][3] - The analysis included participants with different backgrounds, such as those who had used varenicline, bupropion, and nicotine replacement therapy, and categorized them based on their number of previous quit attempts [3][4] - Cytisinicline was shown to benefit individuals regardless of their prior quit history, providing hope for those who have faced setbacks in their attempts to quit smoking [4][3] Group 2: Patient Experience and Safety - Late-breaking survey data from the ORCA-OL study highlighted participant experiences with extended use of cytisinicline, contributing to a comprehensive understanding of its impact on quitting smoking [2][4] - Participants reported meaningful benefits from cytisinicline, including successful quitting and improvements in physical health, emphasizing the importance of patient experience in smoking cessation efforts [5][4] Group 3: Regulatory and Market Context - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline for nicotine dependence, with a New Drug Application submitted to the FDA that is currently under review [7] - The FDA has set a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026, for the cytisinicline application, which is based on successful Phase 3 studies and an open-label safety study [7] - The company has also completed a Phase 2 study for vaping cessation, indicating a broader strategy to address nicotine dependence beyond traditional smoking [7]