Achieve Life Sciences announced the successful topline results from the New Zealand RAUORA Phase III non-inferiority clinical trial comparing cytisinicline to Chantix (varenicline) in Maori (indigenous New Zealanders) and whanau (family) of Maori. The 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.