Achieve Life Sciences Announces Publication in Thorax of Data Demonstrating Cytisinicline’s Potential Efficacy and Tolerability for Smoking Cessation in Individuals with COPD
Achieve Life Sciences (NASDAQ:ACHV) announced the publication of new data in Thorax demonstrating cytisinicline's effectiveness for smoking cessation in patients with chronic obstructive pulmonary disease (COPD). The post hoc analysis of two Phase 3 trials (ORCA-2 and ORCA-3) showed that cytisinicline significantly improved quit rates compared to placebo in both COPD and non-COPD participants.
The study revealed statistically significant increases in continuous smoking abstinence with cytisinicline versus placebo, demonstrating comparable quit rates between COPD and non-COPD groups despite COPD patients having more severe tobacco use histories. The treatment showed a favorable safety profile with no serious treatment-related adverse events.
The FDA has accepted Achieve's New Drug Application for cytisinicline with a PDUFA target date of June 20, 2026. This development is particularly significant as nearly 6 million COPD patients in the U.S. currently smoke, with smoking attributed to 80% of COPD deaths.
Achieve Life Sciences (NASDAQ:ACHV) ha annunciato la pubblicazione di nuovi dati su Thorax che mostrano l'efficacia della cytisinicline per l'arresto del fumo nei pazienti con malattia polmonare cronica (BPCO). L'analisi post hoc di due studi di fase 3 (ORCA-2 e ORCA-3) ha mostrato che la cytisinicline ha significativamente migliorato i tassi di astensione dal fumo rispetto al placebo sia nei partecipanti con BPCO sia in quelli senza BPCO. Lo studio ha evidenziato aumenti statisticamente significativi nell'astinenza continua dal fumo con cytisinicline rispetto al placebo, dimostrando tassi di cessazione simili tra i gruppi BPCO e non-BPCO nonostante i pazienti con BPCO abbiano storie di consumo di tabacco più severe. Il trattamento ha mostrato un profilo di sicurezza favorevole senza eventi avversi gravi correlati al trattamento.
La FDA ha accettato la richiesta di nuovo medicinale di Achieve per la cytisinicline con una data obiettivo PDUFA del 20 giugno 2026. Questo sviluppo è particolarmente significativo poiché quasi 6 milioni di pazienti con BPCO negli Stati Uniti fumano attualmente, con il fumo responsabile dell'80% dei decessi per BPCO.
Achieve Life Sciences (NASDAQ:ACHV) anunció la publicación de nuevos datos en Thorax que demuestran la efectividad de la cytisinicline para dejar de fumar en pacientes con enfermedad pulmonar obstructiva crónica (EPOC). El análisis post hoc de dos ensayos de fase 3 (ORCA-2 y ORCA-3) mostró que la cytisinicline mejoró significativamente las tasas de abandono del tabaco frente a placebo tanto en participantes con EPOC como sin EPOC. El estudio reveló aumentos estadísticamente significativos en la abstinencia continua al tabaco con cytisinicline frente a placebo, demostrando tasas de abandono comparables entre los grupos EPOC y no EPOC a pesar de historiales de consumo de tabaco más severos en los pacientes con EPOC. El tratamiento presentó un perfil de seguridad favorable sin eventos adversos graves relacionados con el tratamiento.
La FDA ha aceptado la solicitud de nuevo fármaco de Achieve para la cytisinicline con una fecha límite de PDUFA del 20 de junio de 2026. Este desarrollo es particularmente significativo ya que casi 6 millones de pacientes con EPOC en EE. UU. fuman actualmente, y el tabaquismo es responsable del 80% de las muertes por EPOC.
Achieve Life Sciences (NASDAQ:ACHV) 은 Thorax에 COPD(만성 폐쇄성 폐질환) 환자에서 흡연 중단에 대한 cytisinicline의 효과를 보여주는 새로운 데이터를 발표했다. 두 개의 3상 연구(ORCA-2 및 ORCA-3)의 후속(post hoc) 분석은 COPD 및 비-COPD 참가자 모두에서 cytisinicline 이 위약에 비해 금연률을 유의하게 향상시켰다고 밝혔다. 연구는 COPD 환자가 더 악화된 흡연 이력을 가짐에도 불구하고 COPD 그룹과 비-COPD 그룹 간의 지속적 금연 여부에서 통계적으로 유의한 증가를 보였으며, 위약에 비해 지속적 금연에 대한 증가를 보여주었다. 치료는 치료 관련 심각한 부작용 없이 안전성 프로파일이 우수했다.
FDA는 cytisinicline에 대한 Achieve의 신약 허가 신청을 수락했으며, PDUFA 목표일은 2026년 6월 20일이다. 이 발전은 미국에서 현재 약 600만 명의 COPD 환자가 흡연 중이며 흡연이 COPD 사망의 80%를 차지한다는 점에서 특히 중요하다.
Achieve Life Sciences (NASDAQ:ACHV) a annoncé la publication de nouvelles données dans Thorax démontrant l'efficacité de la cytisinicline pour l’arrêt du tabac chez les patients atteints de maladie pulmonaire obstructive chronique (MPOC). L’analyse post hoc de deux essais de phase 3 (ORCA-2 et ORCA-3) a montré que la cytisinicline amélioreait significativement les taux d’abstinence du tabac par rapport au placebo chez les participants avec et sans MPOC. L’étude a révélé des augmentations statistiquement significatives des abstinences continues au tabac avec la cytisinicline vs placebo, démontrant des taux d’arrêt comparables entre les groupes MPOC et non-MPOC malgré des antécédents de tabagisme plus sévères chez les patients MPOC. Le traitement a présenté un profil de sécurité favorable sans événements indésirables graves liés au traitement.
La FDA a accepté la demande de médicament nouvelle de Achieve pour la cytisinicline avec une date cible PDUFA du 20 juin 2026. Ce développement est particulièrement significatif car près de 6 millions de patients MPOC aux États-Unis fument actuellement, le tabagisme étant responsable de 80 % des décès liés à la MPOC.
Achieve Life Sciences (NASDAQ:ACHV) gab die Veröffentlichung neuer Daten in Thorax bekannt, die die Wirksamkeit von Cytisinicline bei der Raucherentwöhnung bei Patienten mit chronisch-obstruktiver Lungenerkrankung (COPD) zeigen. Die Post-hoc-Analyse von zwei Phase-3-Studien (ORCA-2 und ORCA-3) zeigte, dass Cytisinicline die Ausstiegsraten aus dem Rauchen im Vergleich zu Placebo signifikant verbesserte – sowohl bei COPD- als auch bei Nicht-COPD-Teilnehmern. Die Studie zeigte signifikante Zuwächse in der kontinuierlichen Raucherabstinenz mit Cytisinicline gegenüber Placebo, was vergleichbare Abbruchraten zwischen COPD- und Nicht-COPD-Gruppen zeigte, obwohl COPD-Patienten schwerere Tabakkonsum-Historien hatten. Die Behandlung wies ein günstiges Sicherheitsprofil auf, ohne schwerwiegende behandlungsbedingte Nebenwirkungen. Die FDA hat Achieves Antrag auf Zulassung von Cytisinicline als neues Medikament akzeptiert, mit einem PDUFA-Zieltermin vom 20. Juni 2026. Diese Entwicklung ist besonders bedeutsam, da in den USA fast 6 Millionen COPD-Patienten derzeit rauchen und Rauchen für 80% der COPD-Todesfälle verantwortlich ist.
Achieve Life Sciences (NASDAQ:ACHV) أعلنت عن نشر بيانات جديدة في مجلة Thorax تُظهر فاعلية السيتيزينِكلين في الإقلاع عن التدخين لدى مرضى الانسداد الرئوي المزمن (COPD). التحليل في مرحلة ما بعد التجربة لثلاثة مَجْلِس المرحلة الثالثة (ORCA-2 و ORCA-3) أظهر أن السيتيزينِكلين حسّن بشكل ملموس معدلات الإقلاع مقارنة بالدواء الوهمي لدى كل من مرضى COPD وغير COPD. كشفت الدراسة عن زيادات ذات دلالة إحصائية في الامتناع المستمر عن التدخين مع السيتيزينِكلين مقابل الوهمي، مما أظهر معدلات إقلاع متشابهة بين مجموعتي COPD وغير COPD رغم أن تاريخ التعاطي لدى مرضى COPD أكثر حدة. كما كان للعلاج ملف سلامة جيد مع عدم وجود أحداث جانبية خطيرة مرتبطة بالعلاج. FDA قبلت طلب Achieve لدواء cytisinicline كدواء جديد مع تاريخ هدف PDUFA في 20 يونيو 2026. هذا التطور ذو أهمية خاصة لأن حوالي 6 ملايين مريض COPD في الولايات المتحدة يدخّنون حاليًا، وأن التدخين هو المسؤول عن نحو 80% من وفيات COPD.
Achieve Life Sciences（纳斯达克：ACHV）宣布在《Thorax》杂志发表的新数据，显示 cytisinicline 在慢性阻塞性肺病（COPD）患者中的戒烟效果。两项第三阶段研究（ORCA-2 和 ORCA-3）的事后分析表明，cytisinicline 相对于安慰剂在 COPD 及非 COPD 受试者中均显著改善戒烟成功率。研究显示，与安慰剂相比，cytisinicline 在持续戒烟方面具有统计学意义的提高，尽管 COPD 患者的烟草使用史更为严重，COPD 与非 COPD 组的戒烟率仍然相当。该治疗具有良好的安全性特征，未出现与治疗相关的严重不良事件。FDA 已接受 Achieve 的 cytisinicline 新药申请，PDUFA 目标日期为 2026 年 6 月 20 日。这一进展尤为重要，因为美国目前大约有 600 万 COPD 患者仍在吸烟，而吸烟占 COPD 死亡的 80%。
- Cytisinicline demonstrated statistically significant improvement in smoking quit rates for both COPD and non-COPD patients
- Treatment showed favorable safety profile with no serious treatment-related adverse events
- FDA accepted New Drug Application for cytisinicline with PDUFA date set
- Successfully completed Phase 2 trial for vaping cessation, expanding potential market
- PDUFA decision not expected until June 2026, indicating lengthy timeline to potential commercialization
Insights
Achieve's cytisinicline shows significant smoking cessation efficacy in COPD patients, addressing a critical treatment gap with FDA decision pending.
This publication in Thorax represents a significant advancement in smoking cessation treatments for a particularly vulnerable population. The post hoc analysis of the Phase 3 ORCA-2 and ORCA-3 trials demonstrates that cytisinicline significantly improved quit rates in smokers with self-reported COPD compared to placebo, despite this population typically having more severe tobacco use histories and previous treatment exposure.
What makes these findings particularly noteworthy is that patients with COPD achieved comparable quit rates to those without COPD, suggesting the drug's efficacy translates well to this high-risk subgroup. The favorable safety profile with no serious treatment-related adverse events addresses a critical need, as tolerability issues often limit adherence to existing cessation therapies.
The data is particularly meaningful considering the CDC reports 6 million COPD patients currently smoke cigarettes, and smoking contributes to 80% of COPD deaths. With limited effective options for this population, a new pharmacologic treatment could significantly impact public health outcomes.
The FDA's acceptance of Achieve's New Drug Application with a PDUFA date of June 20, 2026 indicates we're now in the final regulatory stage. If approved, cytisinicline would provide a novel treatment option for a population that desperately needs additional cessation tools.
This Thorax publication represents a strategic expansion of cytisinicline's potential market positioning. The post hoc analysis is particularly valuable as it identifies a specific high-need subpopulation where the drug shows efficacy, potentially supporting targeted marketing and reimbursement strategies if approved.
The COPD smoking population of 6 million Americans represents a significant commercial opportunity for Achieve. This group typically has higher healthcare utilization and costs, meaning payers and health systems may be particularly receptive to effective cessation options that could reduce long-term expenditures.
Achieve's regulatory strategy appears on track, with the FDA application accepted and a PDUFA date established. The company is building a comprehensive data package by addressing specific populations (COPD smokers) and expanding indications (the completed Phase 2 vaping cessation trial).
If approved next year, cytisinicline would enter a smoking cessation market dominated by decades-old treatments like varenicline and bupropion, potentially offering advantages in safety and tolerability based on the reported adverse event profile. The demonstrated efficacy in a treatment-resistant population strengthens the drug's value proposition to prescribers and payers.
The involvement of prominent researchers like Dr. Judith Prochaska from Stanford adds credibility to the findings and may facilitate broader acceptance among medical key opinion leaders if the drug reaches commercialization.
New data address critical treatment gap for millions of Americans with COPD who face unique smoking cessation challenges
SEATTLE and VANCOUVER, British Columbia, Sept. 22, 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 treatment of nicotine dependence, today announced the publication of new data in Thorax demonstrating that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without chronic obstructive pulmonary disease (COPD).
The Thorax publication, entitled “Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials,” builds on data from over 1,600 participants in two large, randomized, placebo-controlled Phase 3 trials (ORCA-2 and ORCA-3). In this newly published post hoc analysis, researchers evaluated the efficacy and safety of cytisinicline in the subgroup of participants with self-reported COPD, a population at high risk from continued smoking and for whom effective, well-tolerated cessation therapies are urgently needed.
Dr. Judith Prochaska, lead author and Professor of Medicine at Stanford University, said, “COPD patients in our study smoked for many years and had high levels of nicotine addiction. Importantly, we found that cytisinicline significantly increased the odds of quitting for this high-risk group, with an excellent tolerability profile. If approved, cytisinicline would be a new treatment tool for providers in improving health outcomes for millions living with COPD.”
Cytisinicline was associated with robust and statistically significant increases in continuous smoking abstinence compared to placebo for both COPD and non-COPD subgroups. Despite having more severe tobacco use histories and greater prior prescription treatment exposure, participants with COPD achieved quit rates with cytisinicline comparable to those without COPD, supporting cytisinicline as a potential new pharmacologic option for people with COPD who smoke. Importantly, cytisinicline demonstrated a favorable safety profile in both COPD and non-COPD subgroups, with no serious treatment-related adverse events and low rates of common side effects.
“These data highlight the meaningful addition cytisinicline could make for COPD patients who are seeking a safe and effective way to quit smoking,” added Dr. Mark Rubinstein, study co-author and Head of Medical Affairs at Achieve. “For physicians, these results provide much-needed evidence supporting a well-tolerated potential new treatment option for a specific sub-population that traditionally faces significant barriers to successful smoking cessation. This publication reinforces Achieve’s commitment to improving outcomes for patients and empowering healthcare providers with new tools in the fight against nicotine dependence.”
According to U.S. Centers for Disease Control and Prevention (CDC), nearly 16 million U.S. adults reported that they have been diagnosed with COPD. Among those diagnosed with COPD, 6 million reported they currently smoke cigarettes. Given that almost
Achieve recently announced that the FDA accepted its cytisinicline New Drug Application for treatment of nicotine dependence for smoking cessation, with a PDUFA target action date of June 20, 2026. Additionally, the company has completed a Phase 2 trial with cytisinicline in vaping cessation.
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
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 Stakeholders 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 were the key findings of Achieve Life Sciences' cytisinicline COPD study published in Thorax?
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