Achieve Life Sciences, Inc. announced the completion of the fifth and final Data Safety Monitoring Committee (DSMC) review for its Phase 3 ORCA-2 smoking cessation trial of cytisinicline. The DSMC concluded that there are no concerns regarding the Phase 3 study conduct and the safety and adverse event profile remains favorable. Additionally, the DSMC members commented that compliance with study medication was excellent and the study has progressed well despite the challenges of the COVID-19 pandemic. The ORCA-2 trial is designed to evaluate the smoking cessation effectiveness, safety, and tolerability of 3 mg cytisinicline taken three times daily (TID) for either 6 or 12 weeks, compared with placebo. Subjects in the trial have completed study treatment and continue to receive standard behavioral support while completing follow-up assessments through 24 weeks post randomization. Fully enrolled this July, 810 participants were randomized across the 17 clinical sites in the United States. Preliminary data is expected in the first half of 2022.