Achieve Life Sciences Reaches Agreement with the FDA on Long-Term Cytisinicline Exposure Data Requirements for NDA Submission

Open-label exposure trial expected to initiate in Q2’24 with NDA filing anticipated in 1H 2025

SEATTLE and VANCOUVER, British Columbia, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today 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 (ORCA-2, ORCA-3, and ORCA-V1 studies). ORCA-OL will recruit from the more than 1,700 subjects who have participated in these prior trials, including more than 1,100 who have already received cytisinicline treatment for either 6 or 12-weeks. The required total cumulative exposure data for NDA submission and potential final approval will combine the previous subjects’ treatment received during their respective ORCA-2, ORCA-3, or ORCA-V1 study participation plus their exposure during the ORCA-OL study. This allows for faster collection of cumulative long-term exposure safety data for the NDA submission. Subjects in ORCA-OL will receive cytisinicline treatment for up to one year and will be monitored for safety.