Achieve Life Sciences to Advance First Vaping Cessation Therapy After Successful End-of-Phase 2 Meeting with FDA

Core Insights - Achieve Life Sciences has successfully completed its End-of-Phase 2 meeting with the FDA, marking a significant milestone for the development of cytisinicline as a potential first-in-class treatment for nicotine e-cigarette cessation [1][4][6] - The FDA has agreed on the proposed Phase 3 study design for cytisinicline, which includes a well-controlled trial (ORCA-V2) and the use of safety data from an ongoing study for label expansion [2][4] Company Overview - Achieve Life Sciences is focused on developing and commercializing cytisinicline to address nicotine dependence, particularly in the context of e-cigarette and vaping cessation [1][8] - The company has received Breakthrough Therapy designation from the FDA, which has facilitated expedited interactions and feedback during the clinical development process [4][8] Clinical Development - The Phase 3 ORCA-V2 trial is set to evaluate the efficacy and safety of 3 mg cytisinicline administered three times daily for 12 weeks in approximately 800 adults who use e-cigarettes [5][6] - The primary objective of the ORCA-V2 trial is to measure weekly vaping abstinence with biochemical confirmation during the last four weeks of treatment [5] Market Context - There are approximately 11 million adults in the U.S. who use e-cigarettes, with about 60% expressing a desire to quit, highlighting a significant unmet need for effective cessation treatments [3][8] - Currently, there are no FDA-approved treatments specifically for nicotine e-cigarette cessation, positioning cytisinicline as a potential solution in a growing public health challenge [3][8]