Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation
Achieve Life Sciences (NASDAQ: ACHV) has submitted a New Drug Application (NDA) to the FDA for cytisinicline, a novel treatment for nicotine dependence in adult smoking cessation. If approved, cytisinicline would become the first new FDA-approved pharmacotherapy for nicotine dependence in 20 years.
The NDA submission is supported by data from two Phase 3 trials (ORCA-2 and ORCA-3), involving over 2,000 clinical trial participants. Both studies demonstrated significantly higher abstinence rates with cytisinicline compared to placebo at both 6 and 12-week treatment durations. Additional safety data from the ORCA-OL long-term trial, involving over 300 participants with six months of exposure, showed no new safety concerns.
Achieve Life Sciences (NASDAQ: ACHV) ha presentato una Domanda di Nuovo Farmaco (NDA) alla FDA per la cytisinicline, un trattamento innovativo per la dipendenza da nicotina nel contesto della cessazione del fumo negli adulti. Se approvata, la cytisinicline diventerebbe la prima nuova farmacoterapia approvata dalla FDA per la dipendenza da nicotina in 20 anni.
La presentazione della NDA è supportata dai dati di due studi di Fase 3 (ORCA-2 e ORCA-3), che hanno coinvolto oltre 2.000 partecipanti. Entrambi gli studi hanno mostrato tassi di astinenza significativamente più elevati con la cytisinicline rispetto al placebo, sia a 6 che a 12 settimane di trattamento. Ulteriori dati di sicurezza provenienti dallo studio a lungo termine ORCA-OL, con oltre 300 partecipanti e sei mesi di esposizione, non hanno evidenziato nuove preoccupazioni di sicurezza.
Achieve Life Sciences (NASDAQ: ACHV) ha presentado una Solicitud de Nuevo Fármaco (NDA) a la FDA para cytisinicline, un tratamiento novedoso para la dependencia de la nicotina en la cesación del tabaquismo en adultos. Si se aprueba, cytisinicline sería la primera nueva farmacoterapia aprobada por la FDA para la dependencia de la nicotina en 20 años.
La presentación de la NDA está respaldada por datos de dos ensayos de Fase 3 (ORCA-2 y ORCA-3), que involucraron a más de 2.000 participantes. Ambos estudios demostraron tasas de abstinencia significativamente mayores con cytisinicline en comparación con el placebo, tanto a las 6 como a las 12 semanas de tratamiento. Datos adicionales de seguridad del ensayo a largo plazo ORCA-OL, con más de 300 participantes y seis meses de exposición, no mostraron nuevas preocupaciones de seguridad.
Achieve Life Sciences (NASDAQ: ACHV)는 성인 흡연 중단을 위한 니코틴 의존 치료제인 사이티시닐린(cytisinicline)에 대해 FDA에 신약 신청서(NDA)를 제출했습니다. 승인될 경우, 사이티시닐린은 20년 만에 FDA가 승인한 첫 번째 니코틴 의존 치료 신약이 될 것입니다.
이 NDA 제출은 2,000명 이상의 임상 시험 참가자가 참여한 두 개의 3상 시험(ORCA-2 및 ORCA-3)의 데이터를 기반으로 합니다. 두 연구 모두 6주 및 12주 치료 기간 동안 위약 대비 사이티시닐린의 금연 성공률이 유의하게 높음을 보여주었습니다. 또한 300명 이상의 참가자가 6개월간 노출된 장기 시험 ORCA-OL의 추가 안전성 데이터에서는 새로운 안전성 우려가 발견되지 않았습니다.
Achieve Life Sciences (NASDAQ : ACHV) a soumis une demande d’autorisation de mise sur le marché (NDA) à la FDA pour la cytisinicline, un traitement innovant de la dépendance à la nicotine destiné à l’arrêt du tabac chez l’adulte. En cas d’approbation, la cytisinicline deviendrait la première nouvelle pharmacothérapie approuvée par la FDA pour la dépendance à la nicotine depuis 20 ans.
La soumission de la NDA est étayée par des données issues de deux essais de phase 3 (ORCA-2 et ORCA-3), impliquant plus de 2 000 participants. Les deux études ont démontré des taux d’abstinence significativement plus élevés avec la cytisinicline comparativement au placebo, tant à 6 qu’à 12 semaines de traitement. Des données supplémentaires de sécurité provenant de l’essai à long terme ORCA-OL, impliquant plus de 300 participants avec une exposition de six mois, n’ont révélé aucun nouveau problème de sécurité.
Achieve Life Sciences (NASDAQ: ACHV) hat einen Antrag auf Zulassung eines neuen Medikaments (NDA) bei der FDA für Cytisinicline eingereicht, eine neuartige Behandlung der Nikotinabhängigkeit zur Unterstützung der Raucherentwöhnung bei Erwachsenen. Wenn zugelassen, wäre Cytisinicline die erste neue von der FDA zugelassene Pharmakotherapie gegen Nikotinabhängigkeit seit 20 Jahren.
Der NDA-Antrag stützt sich auf Daten aus zwei Phase-3-Studien (ORCA-2 und ORCA-3) mit über 2.000 Studienteilnehmern. Beide Studien zeigten signifikant höhere Abstinenzraten unter Cytisinicline im Vergleich zu Placebo sowohl nach 6 als auch 12 Wochen Behandlung. Zusätzliche Sicherheitsdaten aus der Langzeitstudie ORCA-OL mit über 300 Teilnehmern und einer Expositionsdauer von sechs Monaten zeigten keine neuen Sicherheitsbedenken.
- First potential new FDA-approved smoking cessation treatment in 20 years
- Positive efficacy results from two Phase 3 trials showing significantly higher abstinence rates
- Clean safety profile with no new concerns in long-term trial
- Large market opportunity with 29 million adult smokers in the U.S.
- Comprehensive clinical data package with over 2,000 trial participants
- FDA approval still pending and not guaranteed
- Will face competition from established smoking cessation treatments
- Potential regulatory review and commercialization challenges as a new drug
Insights
Achieve's NDA submission for cytisinicline marks a pivotal regulatory milestone, potentially introducing the first new smoking cessation drug in 20 years.
Achieve Life Sciences has reached a critical regulatory milestone with its New Drug Application submission to the FDA for cytisinicline. The significance cannot be overstated - if approved, this would represent the first new pharmacotherapy for smoking cessation in two decades in a market with remarkably limited treatment options.
The submission is backed by robust clinical evidence from the company's Phase 3 ORCA program. Both the ORCA-2 and ORCA-3 trials demonstrated statistically significant improvements in smoking abstinence rates compared to placebo, both at the end of treatment periods and through the 24-week follow-up. This suggests potentially durable effects beyond the active treatment phase.
Safety data from over 300 participants with extended exposure in the open-label ORCA-OL trial revealed no new safety concerns, a crucial factor for regulatory consideration. The well-tolerated safety profile could represent a competitive advantage if cytisinicline reaches market.
The market opportunity is substantial, with nearly 29 million American adults affected by nicotine dependence. With smoking remaining the leading cause of preventable death and linked to numerous comorbidities including respiratory and cardiovascular diseases and multiple cancer types, there's clear unmet medical need.
While this submission represents progress toward commercialization, investors should recognize that FDA review typically takes 10-12 months, and approval remains uncertain despite promising clinical data. The company will now focus on preparing for potential commercialization while addressing any FDA queries during the review process.
Smoking, the leading cause of preventable death and disease, continues to affect nearly 29 million adults in the U.S. alone
If approved, cytisinicline will be the first new FDA-approved pharmacotherapy option for nicotine dependence in two decades
More than 2,000 clinical trial participants contributed to the body of evidence submitted in the NDA demonstrating cytisinicline’s efficacy, safety, and tolerability profile
SEATTLE and VANCOUVER, British Columbia, June 26, 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 the treatment of nicotine dependence, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults.
“Submitting the cytisinicline NDA represents a decade of research and is a significant milestone toward delivering a new, evidence-based potential treatment for nicotine dependence, an urgent public health challenge with few effective options,” stated Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve Life Sciences. “Smoking-related illnesses claim the lives of nearly half a million people annually in the U.S. alone, and we are committed to making an impact. We look forward to collaborating closely with the FDA during the review process and remain hopeful about the potential of cytisinicline to make a meaningful difference for patients and healthcare providers who are seeking new treatment options.”
The cytisinicline NDA is supported by a combination of efficacy and well-tolerated safety results from two large, placebo-controlled Phase 3 trials, ORCA-2 and ORCA-3, which evaluated cytisinicline for smoking cessation. In both studies, cytisinicline administered for either 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater abstinence rates by the end of treatment and in long-term abstinence through week 24 compared to placebo. The company has also included safety data on over 300 participants with at least six months of cumulative cytisinicline exposure from the open-label long-term trial, ORCA-OL, without any new safety concerns identified by the Data Safety Monitoring Committee.
“The Achieve NDA submission is a significant milestone in our mission to improve the health and well-being of adults who smoke, and to provide a new tool for healthcare providers to aid in the fight against nicotine dependence. The public health burden of smoking is substantial, impairing the lives of up to 29 million Americans who have few treatment options. It is a serious medical condition that has been proven to increase the risk of developing numerous comorbidities, including respiratory and cardiovascular diseases and multiple cancer types. Patients deserve a new medical solution to help address this unmet medical need,” said Rick Stewart, Chief Executive Officer of Achieve Life Sciences. “We would like to express our sincere gratitude to the ORCA Program clinical trial participants and healthcare providers, as well as to our dedicated Achieve team and all those who continue to support our mission to help people live better and healthier lives by overcoming the powerful grip of nicotine dependence.”
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 June 2025, the company submitted its New Drug Application to the FDA for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its fully enrolled 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
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-based 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 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, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, 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.
FAQ
What is the status of Achieve Life Sciences' (ACHV) cytisinicline FDA application?
What clinical trial results support ACHV's cytisinicline NDA submission?
How does cytisinicline differ from existing smoking cessation treatments?
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