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

Rhea-AI Summary

Achieve Life Sciences (NASDAQ: ACHV) received a U.S. FDA Commissioner's National Priority Voucher (CNPV) for cytisinicline as a treatment for nicotine dependence for e-cigarette or vaping cessation on October 17, 2025. The CNPV, one of nine awards in the program's inaugural year, offers enhanced FDA communications and an expedited review window of 1–2 months versus the standard 10–12 months after complete materials are submitted. Cytisinicline showed efficacy in the Phase 2 ORCA-V1 trial (published in JAMA Internal Medicine), with treated participants 2.6 times more likely to quit vaping versus placebo. The drug has FDA Breakthrough Therapy designation and an agreed Phase 3 ORCA-V2 design; an NDA for smoking cessation was accepted with a PDUFA date of June 20, 2026. The company cited ~17 million U.S. adult e-cigarette users and ~60% expressing desire to quit.

Positive

• CNPV awarded, one of nine inaugural vouchers
• Expedited FDA review window reduced to 1–2 months
• ORCA-V1 showed 2.6x higher quit rates vs placebo
• FDA granted Breakthrough Therapy designation
• NDA accepted with PDUFA date June 20, 2026

Negative

• None.

Insights

Regulatory strategist

CNPV award and Breakthrough status materially accelerate regulatory engagement and shorten FDA review timelines.

The CNPV grants Achieve Life Sciences an enhanced FDA communication channel and an expedited assessment window of one to two months after submission versus the typical 10–12 months, which directly shortens the time between final data package submission and a regulatory decision. The FDA has also agreed on the Phase 3 ORCA-V2 design and previously granted Breakthrough Therapy designation, creating a clear regulatory pathway for a vaping-cessation indication when combined with the completed Phase 2 ORCA-V1 data.

Key dependencies and risks include timely completion and submission of the Phase 3 data and the FDA's assessment of the combined dossier; the voucher only shortens review time once a complete submission exists. Monitor the ORCA-V2 enrollment and data submission milestones and the June 20, 2026 PDUFA date for the smoking-cessation NDA as proximate regulatory catalysts within the next 6–12 months.

Commercial and clinical impact analyst

The designation highlights unmet need and could create a first-to-market vaping-cessation therapy with defined clinical support.

Cytisinicline is described as a potential first-in-class pharmacotherapy for nicotine e-cigarette or vaping cessation and showed efficacy in Phase 2 ORCA-V1, where treated participants were 2.6 times more likely to quit versus placebo. The combination of clinical signal, Breakthrough designation, and the CNPV improves the commercial plausibility of establishing a new treatment category for a population the release quantifies as about 17 million U.S. adults, with 60% expressing a desire to quit.

Principal commercial risks are conditional on final Phase 3 outcomes and labeling scope; payor coverage and uptake depend on the observed magnitude and durability of effect in ORCA-V2 and on the FDA-approved indication language. Watch ORCA-V2 topline timing, label scope if approved, and any FDA communications about the CNPV-utilized submission within the coming 6–18 months.

Potential First-in-Class Treatment for Nicotine E-cigarette or Vaping Cessation Receives Unprecedented Expedited Review Pathway

One of Only Nine Therapies Chosen for the FDA’s Inaugural National Priority Voucher Program

SEATTLE and VANCOUVER, British Columbia, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today 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 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 is a potential first-in-class pharmacotherapy specifically indicated for nicotine e-cigarette or vaping cessation. This market represents a significant and growing unmet medical need, with approximately 60% of the 17 million adult e-cigarette users in the United States expressing a desire to quit.

"Achieve is redefining the future of nicotine dependence," said Rick Stewart, Chief Executive Officer of Achieve. "This voucher accelerates our path to potentially pioneering the first and only FDA-approved treatment of nicotine dependence for e-cigarette or vaping cessation, which would establish an entirely new category to serve the millions of people who want to quit vaping. It's been nearly two decades since a new treatment option for smoking cessation was approved, and there are currently no treatment options for vaping cessation. Our message to all Americans struggling with nicotine dependence is, 'We are not quitting on you.'" 

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 (ORCA-V2) that, combined with the completed Phase 2 ORCA-V1 study, would support a supplemental New Drug Application (NDA) for vaping cessation indication.

In the October 16^th press release issued by FDA, Commissioner Marty Makary, M.D., M.P.H. said, “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.”

"The FDA's recognition of vaping cessation as a national priority through this voucher program underscores that nicotine dependence is a medical issue in need of medical intervention," said Dr. Mark Rubinstein, Interim Chief Medical Officer at Achieve.

Separately, Achieve Life Sciences recently announced that the FDA accepted its NDA for cytisinicline for the treatment of nicotine dependence for smoking cessation, with a PDUFA target action date of June 20, 2026.

About Achieve Life Sciences, Inc. 
Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.

About Cytisinicline
There are approximately 29 million adults in the United States who smoke combustible cigarettes.¹ Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.^2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.³

In addition, there are approximately 17 million adults in the United States who use e-cigarettes, also known as vaping.⁴ In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.⁵ There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical need.

Cytisinicline is a plant-derived alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the Food and Drug Administration for any indication in the United States.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements Achieve makes regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Achieve Contact
Nicole Jones
Vice President, Strategic Communications and Stakeholder Relations
ir@achievelifesciences.com
425-686-1510

References
¹VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
³U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
⁴Vahratian A, Briones EM, Jamal A, Marynak KL. Electronic cigarette use among adults in the United States, 2019–2023. NCHS Data Brief, no 524. Hyattsville, MD: National Center for Health Statistics. 2025. DOI: https://dx.doi.org/ 10.15620/cdc/174583.
⁵Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.

FAQ

What did Achieve (ACHV) announce on October 17, 2025 regarding cytisinicline?

Achieve announced the FDA awarded a Commissioner's National Priority Voucher for cytisinicline for e-cigarette/vaping cessation.

How much faster is FDA review with the CNPV for ACHV's cytisinicline?

The CNPV shortens FDA-assessment time to about 1–2 months versus the standard 10–12 months after submission.

What clinical evidence supports cytisinicline for vaping cessation (ACHV)?

In Phase 2 ORCA-V1 (published in JAMA Internal Medicine), cytisinicline-treated participants were 2.6 times more likely to quit vaping versus placebo.

Does cytisinicline have any special FDA designations for ACHV?

Yes; the FDA has granted Breakthrough Therapy designation and agreed on the Phase 3 ORCA-V2 design.

What is the NDA and regulatory timeline for ACHV's cytisinicline for smoking cessation?

The FDA accepted an NDA for smoking cessation with a PDUFA target action date of June 20, 2026.

How large is the U.S. vaping market cited by Achieve (ACHV)?

Achieve cited approximately 17 million adult e-cigarette users in the U.S., with about 60% expressing a desire to quit.