Achieve Life Sciences Secures FDA Commissioner’s Priority Voucher For Cytisinicline To Support Nicotine Cessation In Vaping And E-Cigarette Users

Achieve Life Sciences, Inc., a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for the treatment of nicotine dependence, announced that the U.S. Food and Drug Administration (FDA) has awarded the company a Commissioner’s National Priority Voucher (CNPV) for cytisinicline as a treatment for nicotine dependence specifically for e-cigarette or vaping cessation. This first-of-its-kind designation, granted to only nine therapies in the program’s inaugural year, is designed to provide enhanced FDA communications and expedited review, reducing the FDA-assessment time to one to two months from the standard 10–12 months, once complete materials are submitted for review.

Cytisinicline is a potential first-in-class pharmacotherapy specifically indicated for nicotine e-cigarette or vaping cessation, addressing a significant and growing unmet medical need. Approximately 60% of the 17 million adult e-cigarette users in the United States report a desire to quit. Rick Stewart, Chief Executive Officer of Achieve, stated that the voucher accelerates the company’s path toward potentially pioneering the first and only FDA-approved treatment for nicotine dependence in e-cigarette or vaping cessation. 

He emphasized that this would establish a new treatment category for millions of people seeking to quit vaping. Stewart noted that it has been nearly two decades since a new treatment for smoking cessation was approved, and currently there are no approved therapies for vaping cessation. He added, “Our message to all Americans struggling with nicotine dependence is, ‘We are not quitting on you.’”

Cytisinicline has demonstrated clinical efficacy in the Phase 2 ORCA-V1 trial, published in JAMA Internal Medicine, where participants treated with cytisinicline were 2.6 times more likely to quit using nicotine e-cigarettes or vapes compared to placebo. The FDA has granted cytisinicline Breakthrough Therapy designation for nicotine e-cigarette or vaping cessation and has agreed on the Phase 3 trial design (ORCA-V2). Together with the completed Phase 2 study, these trials will support a supplemental New Drug Application (NDA) for this indication.

In an October 16 press release, FDA Commissioner Marty Makary, M.D., M.P.H., noted, “One of our core goals is to deliver more cures and meaningful treatments especially ones that have an outsized impact on our most pressing national priorities.” Dr. Mark Rubinstein, Interim Chief Medical Officer at Achieve, commented that the FDA’s recognition of vaping cessation as a national priority highlights the need to treat nicotine dependence as a medical condition requiring intervention. Separately, Achieve Life Sciences also announced that the FDA has accepted its NDA for cytisinicline for the treatment of nicotine dependence for smoking cessation, with a PDUFA target action date set for June 20, 2026.