Achieve Life Sciences is developing cytisinicline for use as a smoking cessation treatment in the United States and rest of world. Topline results from ORCA-2 were reported in April 2022 and for ORCA-3 in May 2023. Results exceeded expectations on safety & efficacy parameters. Achieve is conducting the ORCA-OL safety trial which should support an NDA submission by 1H:25 and has completed the six-month portion. Both Phase III trials compare cytisinicline with placebo combined with counseling. The primary endpoint is abstinence at 6 & 12 weeks for the last 4 weeks of treatment. A Phase III trial in vaping cessation (ORCA-V1) reported topline in April 2023. Existing cessation products provide limited effectiveness and produce unpleasant side effects including nausea, vivid dreams, insomnia & GI issues. Cytisinicline may fill a void in the prescription & NRT market by reducing nicotine cravings, severity of withdrawal & reward associated with smoking along with fewer side effects & shorter treatment duration. There are almost 40 million smokers in the US and over 1 billion globally, providing a substantial population demanding an improved smoking cessation product. We anticipate a 2026 commercialization of cytisinicline.
