Achieve Life Sciences announces publication of data on cytisinicline

Achieve Life Sciences (ACHV) announced the publication of new data in Thorax demonstrating that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without chronic obstructive pulmonary disease. The Thorax publication, entitled “Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials,” builds on data from over 1,600 participants in two large, randomized, placebo-controlled Phase 3 trials. In this newly published post hoc analysis, researchers evaluated the efficacy and safety of cytisinicline in the subgroup of participants with self-reported COPD, a population at high risk from continued smoking and for whom effective, well-tolerated cessation therapies are urgently needed. Cytisinicline was associated with robust and statistically significant increases in continuous smoking abstinence compared to placebo for both COPD and non-COPD subgroups. Despite having more severe tobacco use histories and greater prior prescription treatment exposure, participants with COPD achieved quit rates with cytisinicline comparable to those without COPD, supporting cytisinicline as a potential new pharmacologic option for people with COPD who smoke. Importantly, cytisinicline demonstrated a favorable safety profile in both COPD and non-COPD subgroups, with no serious treatment-related adverse events and low rates of common side effects. Achieve recently announced that the FDA accepted its cytisinicline New Drug Application for treatment of nicotine dependence for smoking cessation, with a PDUFA target action date of June 20, 2026. Additionally, the company has completed a Phase 2 trial with cytisinicline in vaping cessation.