Achieve Life Sciences announced complete results from its ORCA-3 trial, published in JAMA Internal Medicine, demonstrating cytisinicline’s efficacy in smoking cessation. The Phase 3 trial involved 792 U.S. adult smokers and confirmed positive results regarding quitting rates and craving reduction at both 6 and 12-week treatment durations, with benefits extending through 24 weeks. An NDA submission is planned for June 2025.
This news holds significant potential for public health, given the substantial mortality and morbidity associated with smoking. Current cessation therapies have limitations in terms of efficacy and tolerability, highlighting the need for new options. Cytisinicline’s targeted mechanism of action, focusing specifically on nicotine receptors, appears to offer an improved side effect profile compared to existing treatments, potentially leading to better patient adherence and ultimately, increased quit rates. This could translate to a significant reduction in smoking-related illnesses and deaths.
The ORCA-3 trial reinforced previously reported topline results, showcasing cytisinicline’s ability to significantly increase quit rates compared to placebo. Furthermore, the treatment reduced nicotine cravings and intake, even among those who didn’t completely quit, as evidenced by lower craving scores and reduced cotinine levels. Participants in the trial mirrored the typical smoker profile, averaging 53 years of age, smoking 20 cigarettes per day, with a 36-year smoking history and multiple prior quit attempts.
The positive results from ORCA-3, coupled with the planned NDA submission in June 2025, position cytisinicline for potential market entry. If approved, this novel therapy could reshape the smoking cessation landscape by offering a more tolerable and effective option for smokers seeking to quit. This holds promise not only for individual health outcomes but also for reducing the societal burden of smoking-related diseases.
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.
