Achieve Life Sciences Hits Key Milestone in Cytisinicline NDA Journey

Achieve Life Sciences, Inc. (Nasdaq: ACHV) has reached a significant milestone in its quest to bring cytisinicline, a novel smoking cessation treatment, to market. The company announced that over 300 participants have completed six months of cumulative cytisinicline treatment in the ORCA-OL clinical trial, fulfilling the long-term exposure requirement for the New Drug Application (NDA) submission. This critical milestone brings Achieve one step closer to its planned NDA submission in the second quarter of 2025.

The ORCA-OL trial, an open-label study designed to evaluate the long-term safety exposure of cytisinicline, has been progressing smoothly. The Data Safety Monitoring Committee (DSMC) has conducted a first review and found no safety concerns, with an overall safety profile that appears excellent. The study is continuing as planned, with no modifications required. Achieve's President and Chief Medical Officer, Cindy Jacobs, PhD, MD, expressed her enthusiasm about this achievement, stating that it advances the company's mission to address the persistent public health challenge of nicotine dependence.



Achieve's cytisinicline has shown promising results in previous Phase 3 clinical trials, with an excellent safety profile and statistically significant increases in the likelihood of quitting nicotine compared to placebo with behavioral support. The company has successfully completed two Phase 3 trials, ORCA-2 and ORCA-3, and a Phase 2 trial for adults who vape nicotine e-cigarettes and desire to quit. In July 2024, the FDA granted Breakthrough Therapy Designation to cytisinicline for the treatment of e-cigarette dependence, further validating the potential of this novel therapy.



The ORCA-OL trial is expected to provide the required longer-term safety data for the cytisinicline NDA submission, which is anticipated in the first half of 2025. Achieve has successfully enrolled over 1,600 subjects in its cytisinicline clinical trials, demonstrating the urgent medical need for a new smoking cessation treatment. The company is well-funded, with approximately $124.2 million in financing, including $60 million upfront from the sale of common stock and up to an additional $64.2 million upon the exercise of milestone-driven warrants.

In conclusion, Achieve Life Sciences has successfully reached a critical milestone in its cytisinicline development journey. With over 300 participants completing six months of cumulative cytisinicline treatment in the ORCA-OL trial, the company is on track to submit its NDA in the second quarter of 2025. The positive safety profile and promising results from previous clinical trials suggest that cytisinicline has the potential to become a valuable addition to the smoking cessation treatment landscape. Investors should closely monitor Achieve's progress as it works towards bringing this novel therapy to market.