Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking Cessation
Achieve Life Sciences (NASDAQ:ACHV) announced the FDA's acceptance of its New Drug Application (NDA) for cytisinicline, a novel smoking cessation treatment. The FDA has set a PDUFA target date of June 20, 2026, marking a significant milestone in potentially introducing the first new FDA-approved smoking cessation pharmacotherapy in two decades.
The NDA is supported by comprehensive data from the ORCA-2 and ORCA-3 Phase 3 trials, involving over 2,000 participants. The trials demonstrated significantly higher smoking abstinence rates with cytisinicline compared to placebo, both at the end of treatment and through week 24. Safety data includes over 400 participants with six-month exposure and 200 with one-year exposure, showing no new safety concerns.
Achieve Life Sciences (NASDAQ:ACHV) ha annunciato che la FDA ha accettato la sua New Drug Application (NDA) per la cytisinicline, un nuovo trattamento per la cessazione del fumo. La FDA ha fissato una PDUFA target date del 20 giugno 2026, un traguardo importante per l’eventuale introduzione della prima nuova farmacoterapia approvata dalla FDA per smettere di fumare in due decenni.
L’NDA si basa su dati completi provenienti dagli studi di Fase 3 ORCA-2 e ORCA-3, che hanno coinvolto oltre 2.000 partecipanti. Gli studi hanno mostrato tassi di astinenza dal fumo significativamente più alti con la cytisinicline rispetto al placebo, sia alla fine del trattamento sia fino alla settimana 24. I dati di sicurezza includono oltre 400 partecipanti con esposizione di sei mesi e 200 con esposizione di un anno, senza nuovi segnali di sicurezza.
Achieve Life Sciences (NASDAQ:ACHV) anunció que la FDA ha aceptado su New Drug Application (NDA) para la citisiniclina, un novedoso tratamiento para dejar de fumar. La FDA ha fijado una fecha objetivo PDUFA del 20 de junio de 2026, marcando un hito importante para la posible introducción de la primera farmacoterapia aprobada por la FDA para dejar de fumar en dos décadas.
La NDA está respaldada por datos exhaustivos de los ensayos de fase 3 ORCA-2 y ORCA-3, que incluyeron a más de 2.000 participantes. Los ensayos demostraron tasas de abstinencia del tabaco significativamente superiores con citisiniclina frente a placebo, tanto al final del tratamiento como hasta la semana 24. Los datos de seguridad comprenden más de 400 participantes con seis meses de exposición y 200 con un año de exposición, sin nuevos problemas de seguridad.
Achieve Life Sciences (NASDAQ:ACHV)는 금연 치료제 시티시니클린(cytisinicline)에 대한 신약허가신청서(NDA)를 FDA가 접수했다고 발표했습니다. FDA는 PDUFA 목표일을 2026년 6월 20일로 정했으며, 이는 20년 만에 처음으로 FDA 승인 가능한 새로운 금연 약물 도입의 중요한 이정표입니다.
이번 NDA는 2,000명 이상이 참여한 ORCA-2 및 ORCA-3 임상 3상 시험의 포괄적인 데이터를 바탕으로 합니다. 해당 시험들은 치료 종료 시점 및 24주차까지 시티시니클린이 위약보다 유의하게 높은 금연 유지 비율을 보였음을 입증했습니다. 안전성 데이터에는 6개월 노출자 400명 이상, 1년 노출자 200명이 포함되어 있으며 새로운 안전성 우려는 관찰되지 않았습니다.
Achieve Life Sciences (NASDAQ:ACHV) a annoncé que la FDA a accepté sa New Drug Application (NDA) pour la cytisinicline, un nouveau traitement pour l’arrêt du tabac. La FDA a fixé une date cible PDUFA au 20 juin 2026, marquant une étape importante pour l’éventuelle introduction de la première pharmacothérapie contre le tabagisme approuvée par la FDA en deux décennies.
La NDA s’appuie sur des données complètes issues des essais de phase 3 ORCA-2 et ORCA-3, impliquant plus de 2 000 participants. Les essais ont montré des taux d’abstinence significativement plus élevés avec la cytisinicline par rapport au placebo, tant à la fin du traitement que jusqu’à la semaine 24. Les données de sécurité comprennent plus de 400 participants exposés pendant six mois et 200 exposés pendant un an, sans nouveaux signaux de sécurité.
Achieve Life Sciences (NASDAQ:ACHV) gab bekannt, dass die FDA seinen New Drug Application (NDA) für Cytisinicline, eine neuartige Therapie zur Raucherentwöhnung, akzeptiert hat. Die FDA hat ein PDUFA-Zieldatum am 20. Juni 2026 festgelegt, was einen wichtigen Meilenstein für die mögliche Einführung der ersten neuen von der FDA zugelassenen Raucherentwöhnungspharmakotherapie seit zwei Jahrzehnten darstellt.
Die NDA stützt sich auf umfassende Daten aus den Phase-3-Studien ORCA-2 und ORCA-3, an denen über 2.000 Teilnehmer beteiligt waren. Die Studien zeigten deutlich höhere Rauchabstinenzraten mit Cytisinicline im Vergleich zu Placebo, sowohl am Ende der Behandlung als auch bis Woche 24. Die Sicherheitsdaten umfassen über 400 Teilnehmer mit sechsmonatiger Exposition und 200 mit einjähriger Exposition und zeigen keine neuen Sicherheitsbedenken.
- FDA acceptance of NDA for cytisinicline marks potential first new smoking cessation drug approval in 20 years
- Strong clinical data from over 2,000 participants showing significant efficacy in Phase 3 trials
- Robust safety profile with no new concerns in long-term exposure studies
- Large market opportunity with 15 million Americans attempting to quit smoking annually
- Extended timeline with PDUFA date set for June 2026
- Commercial launch not expected until second half of 2026, pending FDA approval
Insights
FDA acceptance of Achieve's cytisinicline NDA represents a significant milestone toward potentially the first new smoking cessation drug approval in 20 years.
The FDA's acceptance of Achieve Life Sciences' New Drug Application (NDA) for cytisinicline marks a crucial regulatory milestone in the company's development journey. This acceptance formally initiates the review process with a PDUFA date of June 20, 2026, establishing a clear timeline toward potential commercialization.
The significance of this development cannot be overstated – if approved, cytisinicline would represent the first new FDA-approved pharmacotherapy for smoking cessation in two decades. This highlights both the stagnation in innovation within this therapeutic area and the potential market opportunity for Achieve.
The company's application is supported by robust clinical evidence from the pivotal Phase 3 ORCA-2 and ORCA-3 trials, which demonstrated statistically significant improvements in both short-term and sustained long-term smoking abstinence rates compared to placebo. The comprehensive safety database includes over 400 participants with at least six months of exposure and over 200 with at least one year of exposure, with no new safety signals identified – a critical factor for FDA approval consideration.
From a commercial perspective, Achieve appears strategically positioned with their timeline, targeting commercial readiness for H2 2026. The addressable market is substantial, with an estimated 15 million Americans attempting to quit smoking annually, and smoking-related costs to the American economy exceeding an estimated
While FDA acceptance is not approval, this milestone significantly de-risks the development program and provides clarity on potential commercialization timing. The company must now successfully navigate the FDA review process while simultaneously building commercial infrastructure ahead of a potential launch.
Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation
FDA acceptance starts the review process and sets timing for potentially the first new FDA-approved pharmacotherapy in two decades
PDUFA targeted date set for June 20, 2026
SEATTLE and VANCOUVER, British Columbia, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence, today announced that the U.S. Food and Drug Administration (FDA) has accepted the cytisinicline New Drug Application (NDA) for a new treatment for smoking cessation in adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026.
“The FDA’s acceptance of our NDA validates the totality of our product development program,” said Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve Life Sciences. “Our application is supported by a decade of rigorous research and comprehensive data from thousands of participants. We've built compelling scientific and clinical results as a foundation that, if approved, positions cytisinicline to potentially address a significant medical need. We’re eager to engage constructively with the FDA as we progress through the NDA review process.”
The company’s NDA details a comprehensive clinical development program, with more than 2,000 clinical trial participants contributing to the body of evidence. The ORCA-2 and ORCA-3 Phase 3 trials showed cytisinicline administered for either 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater smoking abstinence rates by the end of treatment and in long-term abstinence through week 24 as compared to placebo. In addition, safety data will include over 400 participants who have received at least six months of cumulative cytisinicline exposure and over 200 participants receiving at least 1 year of cumulative cytisinicline exposure, with no new safety concerns as reported by the Data Safety Monitoring Committee.
“Smoking is the leading cause of preventable death and disease, claiming the lives of nearly half a million Americans each year, and costing the American economy more than an estimated
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 FDA accepted the cytisinicline New Drug Application (NDA) and defined a PDUFA completion date of June 20, 2026. 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
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 unmet 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 dependence for smoking cessation 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 a new investigational product candidate being developed for the 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 its expectation of 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
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.
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