Achieve Life Sciences announced positive safety results from the second review of their ongoing ORCA-OL trial for cytisinicline, a smoking cessation treatment. The Data Safety Monitoring Committee (DSMC) found no unexpected adverse events and noted excellent participant adherence to the medication. Achieve remains on track to submit a New Drug Application (NDA) in Q2 2025.
This positive safety data is crucial for cytisinicline’s potential market entry. It strengthens the drug’s profile, particularly given the substantial public health need for effective smoking cessation therapies. This clean safety record could encourage physician and patient adoption, potentially positioning cytisinicline as a preferred treatment option over existing therapies. Further, it reduces the risk of regulatory delays for the NDA submission, a significant factor for investors and stakeholders.
The ORCA-OL trial, designed to meet FDA safety requirements, enrolled 479 participants and has achieved its goal of 300 participants completing six months of treatment. This milestone was critical for the NDA submission. The trial’s success further validates the safety findings from previous Phase 2 and 3 trials involving over 1,600 subjects. The FDA requires six-month safety data from at least 300 participants and one-year data from 100 participants, which Achieve aims to provide during the NDA review.
This continued positive safety data reinforces Achieve’s progress toward regulatory approval and potential commercialization of cytisinicline. It suggests a higher likelihood of a successful NDA submission and a potentially expedited review process. If approved, cytisinicline could represent the first new prescription smoking cessation treatment in nearly two decades, offering a significant advancement in addressing the public health crisis of nicotine dependence. The anticipated approval could also establish Achieve as a key player in the smoking cessation market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
