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Achieve Life Sciences Announces FDA Acceptance of IND Application for Cytisinicline’s Second Planned Indication for Nicotine E-cigarette Cessation
SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 02, 2021 (GLOBE NEWSWIRE) -- -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 02, 2021 (GLOBE NEWSWIRE) -- -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that the U.S. Food and Drug Administration (FDA) has completed its review and accepted an Investigational New Drug (IND) application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users. There are currently no FDA-approved treatment options indicated to assist in e-cigarette cessation. In addition to the ongoing Phase 3 program for cytisinicline treatment in combustible cigarette cessation, the company expects to initiate the ORCA-V1 e-cigarette and vape cessation trial in the second quarter of 2022. The Phase 2 ORCA-V1 study will enroll approximately 150 adult nicotine e-cigarette users in the U.S. and will be led by Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital and Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve. Grant funding to support the trial has been awarded in two phases from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). Completion of required milestones for the first phase of grant funding included the submission of the IND and clearance to proceed with the clinical trial by FDA. “We are pleased to have reached this critical milestone allowing us to proceed with our clinical development efforts to evaluate the role of cytisinicline across a broader patient population,” stated Cindy Jacobs, President and Chief Medical Officer of Achieve. “There is a significant unmet need for cessation options in a growing number of e-cigarette users who seek to quit and we believe cytisinicline has the potential to play a key role in their success.” The use of e-cigarettes continues to be widespread, with most recent reports from the Centers for Disease Control and Prevention indicating that there were nearly 11 million adult users in the United States alone in 2019. While e-cigarettes have been historically viewed as less harmful than combustible cigarettes, their long-term safety remains controversial. In a recent study conducted by Achieve, ...