Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher for Cytisinicline for Treatment of Nicotine Dependence for E-cigarette or Vaping Cessation

Core Insights - Achieve Life Sciences has received a Commissioner's National Priority Voucher from the FDA for cytisinicline, aimed at treating nicotine dependence specifically for e-cigarette or vaping cessation, marking it as one of only nine therapies in the inaugural year of the program [1][4] - Cytisinicline is positioned as a first-in-class pharmacotherapy for a significant unmet medical need, with around 60% of the 17 million adult e-cigarette users in the U.S. wanting to quit [2][9] - The FDA has granted Breakthrough Therapy designation to cytisinicline, which demonstrated clinical efficacy in the Phase 2 ORCA-V1 trial, showing participants were 2.6 times more likely to quit using nicotine e-cigarettes compared to placebo [3][9] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline to address nicotine dependence and has submitted a New Drug Application (NDA) for smoking cessation, with a target action date of June 20, 2026 [5][6] - The company aims to pioneer the first FDA-approved treatment for vaping cessation, addressing a critical gap in treatment options for nicotine dependence [3][4] Market Context - There are approximately 29 million adults in the U.S. who smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, responsible for over 8 million deaths globally [7][8] - The vaping market is also significant, with around 17 million adults in the U.S. using e-cigarettes, and no FDA-approved treatments currently available for vaping cessation [9][10]