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Achieve Announces Successful Results from the Investigator-Initiated RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix® (varenicline) as a Treatment to Quit Smoking
Cytisinicline demonstrated quit rates at least as effective as varenicline Participants on cytisinicline experienced significantly fewer side effects than
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Cytisinicline demonstrated quit rates at least as effective as varenicline\nParticipants on cytisinicline experienced significantly fewer side effects than those on varenicline\n SEATTLE and VANCOUVER, BC, June 29, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced the successful topline results from the New Zealand RAUORA Phase 3 non-inferiority clinical trial comparing cytisinicline to varenicline (Chantix®) in Māori (indigenous New Zealanders) and whānau (family) of Māori. The study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and was funded by the Health Research Council of New Zealand. \n\n \n \n \n \n \n \n\n \nThe RAUORA trial was designed to evaluate the effectiveness, safety, and cost-effectiveness of cytisinicline compared to varenicline as a smoking cessation aid. In total, the study randomized 679 subjects to receive 12 weeks of either cytisinicline or varenicline. The primary endpoint was a comparison of biochemically confirmed continuous abstinence rates at 6 months, and the trial was designed to assess if the two agents were non-inferior to each other. The trial achieved statistical significance in showing that cytisinicline plus behavioral support was at least as effective as varenicline plus behavioral support at six months. In addition, the trial showed that cytisinicline resulted in significantly fewer reported adverse events when compared to varenicline. The final RAUORA trial results have been submitted for presentation at The Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting in September 2020. \n\"The positive topline results of the RAUORA Phase 3 trial, which is the first, direct head-to-head comparative study between cytisinicline and varenicline, provide additional evidence that cytisinicline is at least as effective as varenicline while offering improved tolerability,\" said Rick Stewart, Chairman and Chief Executive Officer of Achieve. \"Importantly, these benefits were achieved using a lower dose of cytisinicline. Future cytisinicline clinical trials, sponsored by Achieve, will use a higher dose and optimized dosing schedule, and we believe that this c...