Achieve Life Sciences receives FDA CNPV for cytisinicline

Achieve Life Sciences (ACHV) announced that the U.S. Food and Drug Administration has awarded the company a Commissioner’s National Priority Voucher for cytisinicline as a treatment of nicotine dependence for e-cigarette or vaping cessation. This first-of-its-kind designation, available to only nine therapies in the program’s inaugural year, is designed to provide enhanced FDA communications and expedited review that reduces FDA-assessment time to one to two months from the standard 10-12 months, once complete materials are submitted for FDA review. Cytisinicline 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 that, combined with the completed Phase 2 ORCA-V1 study, would support a supplemental New Drug Application for vaping cessation indication.