Cytisinicline - (ORCA-3)

Oct. 17, 2025: Achieve Life Sciences, Inc. (NASDAQ: ACHV) said the FDA awarded a Commissioner’s National Priority Voucher (CNPV) for cytisinicline for nicotine dependence related to e-cigarette/vaping cessation. The voucher, part of the FDA’s inaugural National Priority Voucher Program (limited to nine therapies), is intended to provide enhanced FDA communications and an expedited review pathway that can reduce FDA assessment time to 1–2 months from the standard 10–12 months once complete materials are submitted.

The company said cytisinicline has FDA Breakthrough Therapy designation for vaping cessation. It cited Phase 2 ORCA-V1 results (published in JAMA Internal Medicine) in which cytisinicline-treated participants were 2.6x more likely to quit vaping vs placebo. Achieve stated the FDA has agreed on the Phase 3 ORCA-V2 design; ORCA-V2 plus ORCA-V1 is intended to support a supplemental NDA for a vaping cessation indication.

Separately, Achieve noted the FDA accepted its NDA for cytisinicline for adult smoking cessation, with a PDUFA target action date of June 20, 2026.