Achieve Reveals Agreement With FDA On Long-term Cytisinicline Exposure Data For Safety Risks

(RTTNews) - Late-stage pharma company Achieve Life Sciences, Inc. (ACHV) Thursday announced that it has reached an agreement with FDA, so that a single, open-label study evaluating long-term safety exposure of Cytisinicline will be sufficient to complete and adequately evaluate safety risks. Further, the company expects an NDA submission in the first half of 2025.

Earlier, during pre-NDA discussions in 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.

FDA had also advised long-term exposure data to assess safety beyond 12 weeks.

Achieve said its NDA submission will include safety data on at least 300 subjects who have received cumulative Cytisinicline treatment for six months. Further, before the approval, Achieve will provide safety data from at least 100 subjects treated with Cytisinicline for a cumulative duration of one year.

In another development, Achieve received approximately $124.2 million in financing, which includes $60 million upfront from the sale of common stock and up to an additional $64.2 million upon the exercise of milestone-driven warrants.