Achieve Life Sciences Announces Critical Milestone Successfully Reached in ORCA-OL Cytisinicline Clinical Trial Required for NDA Submission
Achieve Life Sciences (NASDAQ: ACHV) has reached a critical milestone in its ORCA-OL clinical trial, with over 300 participants completing six months of cumulative cytisinicline treatment for smoking cessation. This achievement fulfills a key FDA requirement for the planned New Drug Application (NDA) submission, which remains on track for Q2 2025.
The Data Safety Monitoring Committee review has identified no safety concerns, and the study continues as planned. The FDA has previously expressed support for the NDA submission based on data from two completed Phase 3 trials (ORCA-2 and ORCA-3), which assessed efficacy for six-week and 12-week treatment durations.
The FDA requires both six-month and one-year exposure safety data, with the latter to be submitted prior to potential NDA approval. To date, Achieve has completed two Phase 3 trials involving more than 1,600 subjects who smoke cigarettes or vape nicotine e-cigarettes.
Achieve Life Sciences (NASDAQ: ACHV) ha raggiunto un traguardo significativo nel suo studio clinico ORCA-OL, con oltre 300 partecipanti che hanno completato sei mesi di trattamento cumulativo con citisinicline per la cessazione del fumo. Questo risultato soddisfa un requisito fondamentale della FDA per la prevista presentazione della Domanda di Nuovo Farmaco (NDA), che è ancora in programma per il secondo trimestre del 2025.
La revisione del Comitato per la Sicurezza dei Dati non ha evidenziato preoccupazioni di sicurezza, e lo studio continua come previsto. La FDA ha precedentemente espresso supporto per la presentazione della NDA basata sui dati di due trial di Fase 3 completati (ORCA-2 e ORCA-3), che hanno valutato l'efficacia per durate di trattamento di sei e dodici settimane.
La FDA richiede dati di sicurezza sia per un'esposizione di sei mesi che di un anno, con quest'ultimi da presentare prima dell'eventuale approvazione della NDA. Fino ad oggi, Achieve ha completato due trial di Fase 3 coinvolgendo più di 1.600 soggetti che fumano sigarette o utilizzano sigarette elettroniche contenenti nicotina.
Achieve Life Sciences (NASDAQ: ACHV) ha alcanzado un hito crítico en su ensayo clínico ORCA-OL, con más de 300 participantes que completaron seis meses de tratamiento acumulativo con citisiniclina para dejar de fumar. Este logro cumple con un requisito clave de la FDA para la presentación planeada de la Solicitud de Nuevo Medicamento (NDA), que se mantiene en el camino para el segundo trimestre de 2025.
La revisión del Comité de Monitoreo de Seguridad de Datos no ha identificado preocupaciones de seguridad, y el estudio continúa según lo planeado. La FDA ha expresado previamente su apoyo a la presentación de la NDA basada en datos de dos ensayos de Fase 3 completados (ORCA-2 y ORCA-3), que evaluaron la eficacia para duraciones de tratamiento de seis y doce semanas.
La FDA requiere datos de seguridad tanto de seis meses como de un año, siendo estos últimos necesarios antes de una posible aprobación de la NDA. Hasta la fecha, Achieve ha completado dos ensayos de Fase 3 con más de 1,600 sujetos que fuman cigarrillos o vaporizan e-cigarrillos con nicotina.
Achieve Life Sciences (NASDAQ: ACHV)는 흡연 중단을 위한 사이티신클린 치료를 6개월 동안 300명 이상의 참가자가 완료한 ORCA-OL 임상 시험의 중요한 이정표에 도달했습니다. 이 성과는 FDA의 신규 의약품 승인(NDA) 신청을 위한 핵심 요건을 충족하며, 2025년 2분기를 목표로 하고 있습니다.
데이터 안전성 모니터링 위원회의 검토에서는 안전성 문제를 확인하지 않았으며, 연구는 계획대로 계속 진행됩니다. FDA는 이전에 완료된 두 건의 3상 시험(ORCA-2 및 ORCA-3)의 데이터를 바탕으로 NDA 제출에 대한 지원을 표명했습니다. 이 시험들은 각각 6주 및 12주 치료 기간의 효능을 평가했습니다.
FDA는 6개월 및 1년 노출 안전성 데이터를 요구하며, 후자는 NDA 승인 가능성 이전에 제출되어야 합니다. 현재까지 Achieve는 1,600명 이상의 흡연자 또는 니코틴 전자담배 사용자로 구성된 두 건의 3상 시험을 완료했습니다.
Achieve Life Sciences (NASDAQ: ACHV) a atteint une étape cruciale dans son essai clinique ORCA-OL, avec plus de 300 participants ayant complété six mois de traitement cumulatif par cytisinicline pour aider à l'arrêt du tabac. Cette réussite satisfait à une exigence clé de la FDA pour la soumission prévue de la Demande d'Autorisation de Mise sur le Marché (NDA), qui reste sur la bonne voie pour le deuxième trimestre 2025.
L'examen du Comité de Surveillance des Données de Sécurité n'a identifié aucun problème de sécurité, et l'étude se poursuit comme prévu. La FDA a précédemment exprimé son soutien à la soumission de la NDA basée sur les données de deux essais de Phase 3 achevés (ORCA-2 et ORCA-3), qui ont évalué l'efficacité pour des durées de traitement de six et douze semaines.
La FDA exige des données de sécurité à la fois pour une exposition de six mois et d'un an, cette dernière devant être soumise avant une éventuelle approbation de la NDA. À ce jour, Achieve a complété deux essais de Phase 3 impliquant plus de 1 600 sujets ayant fumé des cigarettes ou utilisant des e-cigarettes contenant de la nicotine.
Achieve Life Sciences (NASDAQ: ACHV) hat einen entscheidenden Meilenstein in seiner klinischen Studie ORCA-OL erreicht, in der über 300 Teilnehmer sechs Monate lang kumulativ mit Cytisin behandelt wurden, um mit dem Rauchen aufzuhören. Dieser Erfolg erfüllt eine wesentliche Anforderung der FDA für die geplante Einreichung der New Drug Application (NDA), die planmäßig für das zweite Quartal 2025 ansteht.
Die Überprüfung des Data Safety Monitoring Committee hat keine Sicherheitsbedenken festgestellt, und die Studie läuft wie geplant weiter. Die FDA hat zuvor ihre Unterstützung für die NDA-Einreichung bekundet, basierend auf Daten von zwei abgeschlossenen Phase-3-Studien (ORCA-2 und ORCA-3), die die Wirksamkeit bei Behandlungsdauern von sechs und zwölf Wochen bewerteten.
Die FDA verlangt sowohl Sicherheitsdaten für die sechsmonatige als auch für die einjährige Exposition, wobei letztere vor einer möglichen NDA-Zulassung eingereicht werden müssen. Bisher hat Achieve zwei Phase-3-Studien mit mehr als 1.600 Teilnehmern, die Zigaretten rauchen oder Nikotin-E-Zigaretten dampfen, abgeschlossen.
- Achieved FDA-required milestone of 300+ participants completing 6-month treatment
- No safety concerns identified in ongoing trial
- NDA submission timeline remains on track for Q2 2025
- FDA support received for NDA submission based on completed Phase 3 trials
- Successfully completed two Phase 3 trials with over 1,600 subjects
- One-year exposure safety data still pending and required for final NDA approval
Insights
The successful completion of 6-month cumulative safety data collection from 300+ participants marks a critical regulatory milestone for ACHV's cytisinicline development program. The clean safety profile observed by the DSMC and adherence to timeline targets significantly de-risks the upcoming NDA submission. The FDA's acceptance of a rolling submission approach for safety data (6-month data in initial submission, 1-year data before approval) provides regulatory flexibility while maintaining momentum toward potential approval.
The previously completed ORCA-2 and ORCA-3 Phase 3 trials, involving over 1,600 subjects, have already demonstrated efficacy for both 6-week and 12-week treatment durations. This robust efficacy dataset, combined with the emerging long-term safety profile, strengthens the overall regulatory package. If approved, cytisinicline would be the first new smoking cessation treatment in nearly 20 years, addressing a significant unmet medical need in a market dominated by existing options with known limitations.
This milestone substantially increases the probability of successful NDA submission and potential approval, which is important for ACHV's
The clean safety profile observed so far is particularly important for commercial prospects, as safety concerns have historically the adoption of existing smoking cessation treatments. The drug's novel mechanism and dosing regimen (3mg three times daily) could provide a competitive advantage. The company's focused development strategy and efficient execution of clinical trials demonstrate strong operational capabilities, which will be important for successful commercialization if approved.
Over 300 Participants Have Completed Cumulative Six Months of Cytisinicline Treatment in the ORCA-OL Trial, Completing the Long-Term Exposure Requirement for NDA Submission
ORCA-OL Long-Term Exposure Timelines Remain on Track with No Safety Concerns Identified
Planned Cytisinicline NDA Submission on Target for Q2 2025
SEATTLE and VANCOUVER, British Columbia, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation as a treatment for nicotine dependence, today announced that its ongoing ORCA-OL clinical trial, designed to evaluate the long-term safety exposure of cytisinicline, has reached the goal of at least 300 participants completing six months of cumulative cytisinicline treatment. The U.S. Food and Drug Administration (FDA) requested six-month safety exposure data to be included in the company’s planned New Drug Application (NDA). Further, based on ongoing Data Safety Monitoring Committee (DSMC) review, no safety concerns have been identified, and the study continues to proceed as planned with no modifications. Achieve remains on track for the planned NDA submission, expected to occur in the second quarter of 2025.
“Achieving this critical milestone for the NDA submission clearly advances our mission to bring treatment to people who struggle with nicotine dependence,” stated Cindy Jacobs, Ph.D., M.D., President and Chief Medical Officer of Achieve. “We are deeply grateful to the clinical sites and participants for their continued commitment and dedication in helping bring a new therapy for nicotine dependence forward, one which aims to help address a persistent public health challenge.”
In late 2023 pre-NDA discussions, the FDA expressed its support for an NDA submission based on sufficient data from the two completed randomized, controlled Phase 3 trials, ORCA-2 and ORCA-3, to assess efficacy for cytisinicline six-week and 12-week treatment durations. The FDA also requested cytisinicline exposure data out to six months and one year to evaluate adequate longer-term safety risks, given that smoking cessation drugs are intended for chronic, repeated, or intermittent use, as patients may relapse and require repeated treatments. The FDA agreed to having the six-month cumulative exposure safety data submitted in the NDA submission and the one-year cumulative exposure safety data submitted later, prior to potential NDA approval.
“The completion of the cumulative six-month treatment reflects the dedication of our team and study participants, bringing us closer to our goal of potentially becoming the first new FDA-approved smoking cessation treatment in nearly two decades,” said Rick Stewart, Chief Executive Officer of Achieve. “As we move forward, our team remains focused on fulfilling all NDA-related requirements and ensuring cytisinicline reaches those who need it most.”
To date, Achieve has successfully completed two Phase 3 clinical trials of cytisinicline in more than 1,600 subjects who either smoke cigarettes or vape nicotine e-cigarettes and have the desire to quit. The ORCA-OL clinical trial continues to evaluate longer-term safety exposure of the novel 3 mg cytisinicline three times a day dosing regimen in individuals who want to end their nicotine dependence.
About ORCA-OL Trial
ORCA-OL is an open-label trial designed to evaluate the long-term exposure of 3 mg cytisinicline treatment dosed three times daily in adults 18 years of age or older who want to quit smoking or vaping and is being conducted at 29 clinical sites across the United States. The trial results are expected to meet the FDA's requirement for safety data from at least 300 participants treated with cytisinicline over a cumulative six-month period for the NDA submission. Additionally, data on at least 100 subjects treated for a cumulative one-year period will be provided prior to potential product approval.
About Achieve Life Sciences, Inc.
Achieve Life Sciences is a specialty pharmaceutical company committed to addressing the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in Q2 2025. Achieve has conducted a successful end-of-Phase 2 meeting with the FDA for the vaping indication and expects to initiate its single Phase 3 clinical study in vaping later in 2025.
About Cytisinicline
There are approximately 29 million adults 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 over 11 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 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 for the treatment of nicotine addiction 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 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 inflation, volatile interest 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.
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.
4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.
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
When will Achieve Life Sciences (ACHV) submit its NDA for cytisinicline?
How many participants completed the 6-month cytisinicline treatment in ORCA-OL trial?
What are the safety findings from ACHV's ORCA-OL cytisinicline trial?
How many subjects participated in ACHV's completed Phase 3 trials for cytisinicline?
What FDA requirements must ACHV meet for cytisinicline approval?
