Cytisinicline demonstrated quit rates at least as effective as varenicline

Participants on cytisinicline experienced significantly fewer side effects than those on varenicline

SEATTLE, Wash and VANCOUVER, British Columbia, June 29, 2020 — 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.

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 significan