On October 18, 2025, Achieve Life Sciences announced that the U.S. Food and Drug Administration (FDA) has awarded the company a Commissioner's National Priority Voucher (CNPV) for cytisinicline, a plant‑derived alkaloid intended to treat nicotine dependence in e‑cigarette or vaping users.
The voucher, part of the FDA’s inaugural National Priority Voucher Program, is available to only nine therapies in its first year and is designed to provide enhanced FDA communications and an expedited review that reduces assessment time to one‑to‑two months from the standard 10‑12 months once complete materials are submitted. This accelerated pathway could bring cytisinicline to market significantly earlier than the typical regulatory timeline for a new drug.
Cytisinicline has already demonstrated clinical efficacy in the Phase 2 ORCA‑V1 trial, where patients treated with the drug were 2.6 times more likely to quit vaping compared to placebo. The FDA’s voucher, combined with the drug’s Breakthrough Therapy designation and the agreed Phase 3 trial design (ORCA‑V2), positions Achieve to potentially file a supplemental New Drug Application for vaping cessation in the near future.
The award is a strategic milestone for Achieve, as it not only signals strong regulatory support but also enhances the company’s competitive positioning in a market that currently lacks approved pharmacotherapies for vaping cessation. With approximately 17 million U.S. adults using e‑cigarettes and 60% expressing a desire to quit, cytisinicline could capture a substantial share of a growing unmet need.
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