Achieve Life Sciences Advances Cytisinicline NDA with Positive ORCA-OL Safety Review

Achieve Life Sciences has received a positive safety review from the Data Safety Monitoring Committee (DSMC) for its ongoing ORCA-OL trial, reinforcing the safety profile of cytisinicline for smoking cessation. The DSMC’s independent evaluation found no unexpected adverse events, with high adherence among trial participants. With 479 individuals enrolled, including over 300 completing six months of treatment, Achieve remains on track to submit its New Drug Application (NDA) for cytisinicline next quarter.

CEO Rick Stewart emphasized that cytisinicline could become the first new prescription smoking cessation treatment in nearly two decades, addressing a critical public health need. The ORCA-OL trial is designed to meet the FDA’s long-term safety requirements, further validating the drug’s potential. With two successful Phase 3 trials completed in over 1,600 participants, Achieve continues its mission to provide a groundbreaking solution for nicotine dependence.