Achieve Life reaches agreement with FDA on cytisinicline data requirements

Achieve Life Sciences announced that it has reached agreement with the U.S. Food and Drug Administration, FDA, on the adequacy and timing of long-term cytisinicline exposure data requirements for a New Drug Application, NDA. During pre-NDA discussions held in the fourth quarter of 2023, the FDA expressed support for an NDA submission based on adequate data to assess for efficacy from the two completed randomized and controlled Phase 3 trials, ORCA-2 and ORCA-3. In addition, the FDA advised that long-term exposure data to assess for safety beyond 12 weeks would be needed to adequately evaluate safety risks given that the FDA views smoking cessation drugs as products for chronic, repeat, or intermittent use as patients may relapse and require subsequent courses of treatment over a lifetime. Achieve and the FDA have reached agreement that a single, open-label study evaluating for long-term safety exposure of cytisinicline will be sufficient to complete the requirement and enable an NDA submission anticipated in the first half of 2025. Based on FDA agreement, Achieve’s NDA submission will include safety data on at least 300 subjects who have received cumulative cytisinicline treatment for six months. Prior to potential approval, Achieve will provide the FDA with safety data from at least 100 subjects treated with cytisinicline for a cumulative duration of one year. Achieve plans to initiate the “ORCA-OL” open label exposure trial in the second quarter of 2024, which will include investigators and sites who have participated in the ORCA clinical trial program .