Achieve Life Sciences, Inc. announced that the last study follow-up visit for the last subject enrolled in the Phase 2 ORCA-V1 trial has occurred. ORCA-V1 is evaluating the efficacy and safety of cytisinicline in adult users of nicotine e- cigarettes, or vapes, and is being supported in part through grant funding from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). The ORCA-V1 trial randomized 160 adult users of nicotine e- vaping across 5 clinical trial locations in the United States.

Participants were randomized 2 to 1 to receive either 3 mg of cytisinicline three times daily or placebo three times daily, for a period of 12 weeks. Patients also received standardized behavioral support throughout the trial. The primary endpoint is continuous abstinence during the final 4 weeks of treatment.

Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital is the primary investigator for the ORCA-V1 trial.