Achieve Life Sciences Meets Key Milestones Advancing Cytisinicline NDA for Smoking Cessation

Core Insights - Achieve Life Sciences has made significant progress in the regulatory process for cytisinicline, a treatment for nicotine dependence, with the completion of the ORCA-OL long-term safety trial and submission of a 120-day safety update to the FDA [1][2][7] Company Developments - The ORCA-OL trial successfully concluded with 334 participants completing one year of treatment, surpassing FDA requirements for safety data [3][7] - The Data Safety Monitoring Committee (DSMC) conducted its final review and found no safety concerns related to cytisinicline, indicating a favorable safety profile [2][7] - The company submitted a New Drug Application (NDA) to the FDA in June 2025, which has been accepted for review, with a Prescription Drug User Fee Act (PDUFA) date set for June 20, 2026 [5] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, highlighting the critical need for effective smoking cessation treatments [6] - There are currently no FDA-approved treatments specifically for e-cigarette cessation, indicating a significant market opportunity for cytisinicline [8][9]