Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial

Core Viewpoint - Achieve Life Sciences is progressing towards the submission of a New Drug Application (NDA) for cytisinicline, a treatment for nicotine dependence, following a positive safety review from the Data Safety Monitoring Committee (DSMC) [1][2][3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for smoking cessation and nicotine dependence [7][8] - The company has completed two Phase 3 clinical trials involving over 1,600 subjects who smoke cigarettes and wish to quit [5] Clinical Trial Details - The ORCA-OL trial is an open-label study evaluating the long-term exposure of a 3 mg cytisinicline treatment regimen, dosed three times daily, in adults aged 18 and older who want to quit smoking or vaping [6] - The trial has enrolled 479 participants across 29 clinical sites in the United States, with a significant milestone achieved as at least 300 participants completed six months of treatment [3][4] Safety Review Findings - The DSMC's second independent review found no unexpected treatment-related adverse events, confirming the overall safety profile of cytisinicline consistent with previous trials [2][3] - The study can continue as planned without modifications, reinforcing confidence in the cytisinicline safety profile [2][3] Regulatory Pathway - Achieve plans to submit the NDA in Q2 2025, which will be the first new prescription treatment for nicotine dependence in nearly 20 years [4] - The FDA requires six-month safety exposure data from at least 300 participants and one-year cumulative exposure data from a minimum of 100 participants for NDA approval [4][6] Market Context - Approximately 29 million adults smoke combustible cigarettes, and tobacco use is the leading cause of preventable death globally [9][10] - There are over 11 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation [10][11]