Achieve Life Sciences, Inc. announced that the final subject of the Company's Phase 2 ORCA-V1 trial has completed treatment in the study. 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-cigarettes across 5 clinical trial locations in the United States.

Participants were randomized into two arms to either receive 3 mg of cytisinicline three times daily, or placebo, 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. The research and clinical study discussed in this release is supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) under Award Number 4R44DA054784-02. The content is the sole responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.