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Achieve Life Sciences Announces Last Subject Dosed in Phase 2 ORCA-V1 Trial of Cytisinicline for e-Cigarette Cessation
Topline Data Expected in 2Q 2023 SEATTLE, Wash and VANCOUVER, British Columbia, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV),
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Topline Data Expected in 2Q 2023\nSEATTLE, Wash and VANCOUVER, British Columbia, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today 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). “There are currently no FDA-approved treatments specifically indicated for nicotine e-cigarette cessation, representing a unique opportunity for cytisinicline should it show a vaping cessation benefit in our randomized clinical trials,” stated John Bencich, Chief Executive Officer of Achieve. “We look forward to reporting topline results from the Phase 2 ORCA-V1 trial, and separately, ORCA-3, our second Phase 3 trial in smoking cessation in the second quarter of this year.”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.For more information on cytisinicline or the ORCA-V1 trial, please visit www.achievelifesciences.com.The research and clinical study discussed in this press 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.About Achieve and Cytisinicline Achieve’s focus is to address the global smoking health and nicotine addiction epid...