Achieve Life Sciences Announces Critical Milestone Successfully Reached in ORCA-OL Cytisinicline Clinical Trial Required for NDA Submission

Core Insights - Achieve Life Sciences has reached a significant milestone in its ORCA-OL clinical trial, with over 300 participants completing six months of cumulative treatment with cytisinicline, which is essential for the New Drug Application (NDA) submission [2][3][4] - The FDA has requested six-month safety exposure data for the NDA, and no safety concerns have been identified during the ongoing review [2][3] - The planned NDA submission for cytisinicline is on track for Q2 2025, aiming to address nicotine dependence and smoking cessation [2][4] Company Overview - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, having completed two Phase 3 trials involving over 1,600 subjects [6][4] - The company has received Breakthrough Therapy designation for cytisinicline, highlighting its potential to meet an urgent public health need [8][9] - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors to help reduce nicotine cravings and dependence [9] Clinical Trial Details - The ORCA-OL trial is an open-label study evaluating the long-term safety of a 3 mg cytisinicline regimen taken three times daily, conducted at 29 clinical sites across the U.S. [5][4] - The trial aims to provide safety data from at least 300 participants for the NDA submission, with additional data from at least 100 subjects treated for a cumulative one-year period to be submitted prior to potential product approval [5][4] Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [7][8] - There are over 11 million adults in the U.S. who use e-cigarettes, and currently, there are no FDA-approved treatments specifically for nicotine e-cigarette cessation [8][9]