AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease
AbbVie (NYSE:ABBV) has submitted a New Drug Application (NDA) to the FDA for tavapadon, a novel once-daily oral treatment for Parkinson's disease. The submission is supported by positive results from the Phase 3 TEMPO clinical program, which demonstrated significant efficacy across multiple trials.
The TEMPO program included three Phase 3 trials: TEMPO-1 and TEMPO-2 showed statistically significant improvement in MDS-UPDRS Parts II and III scores in early Parkinson's patients, while TEMPO-3 demonstrated increased "on" time in patients using tavapadon as an adjunctive therapy to levodopa. The submission also includes interim data from the TEMPO-4 open-label extension trial.
AbbVie (NYSE:ABBV) ha presentato alla FDA una Domanda di Nuovo Farmaco (NDA) per tavapadon, un innovativo trattamento orale una volta al giorno per la malattia di Parkinson. La presentazione è supportata da risultati positivi del programma clinico di fase 3 TEMPO, che ha dimostrato un’efficacia significativa in diversi studi.
Il programma TEMPO comprendeva tre studi di fase 3: TEMPO-1 e TEMPO-2 hanno mostrato un miglioramento statisticamente significativo dei punteggi MDS-UPDRS, parti II e III, nei pazienti in fase iniziale di Parkinson, mentre TEMPO-3 ha evidenziato un aumento del tempo di stato di funzionamento sovrapposto a tavapadon come terapia aggiuntiva alla levodopa. La presentazione include anche dati intermedi del trial di estensione aperto TEMPO-4.
AbbVie (NYSE:ABBV) ha presentado a la FDA una Solicitud de Nuevo Fármaco (NDA) para tavapadon, un novedoso tratamiento oral diario para la enfermedad de Parkinson. La presentación está respaldada por resultados positivos del programa clínico de fase 3 TEMPO, que demostró una eficacia significativa en varios ensayos.
El programa TEMPO incluyó tres ensayos de fase 3: TEMPO-1 y TEMPO-2 mostraron mejoras estadísticamente significativas en las puntuaciones MDS-UPDRS, partes II y III, en pacientes con Parkinson en etapas tempranas, mientras que TEMPO-3 demostró un aumento del tiempo de movilidad cuando tavapadon se usa como terapia adyuvante a la levodopa. La presentación también incluye datos provisionales del ensayo de extensión abierto TEMPO-4.
AbbVie (NYSE:ABBV)가 FDA에 파생 신약(NDA)을 제출했습니다. 타바파돈은 파킨슨병에 대한 새롭고 매일 한 번 복용하는 경구 치료제입니다. 제출은 TEMPO 3상 임상 프로그램의 긍정적 결과를 뒷받침하며 여러 시험에서 유의한 효능을 보였습니다.
TEMPO 프로그램은 TEMPO-1 및 TEMPO-2가 파킨슨병 초기 환자에서 MDS-UPDRS II/III 점수의 통계적으로 유의한 개선을 보였고, TEMPO-3은 레보도파 보조 요법으로 tavapadon을 사용하는 환자에서 작동 시간(on) 증가를 시연했습니다. 제출에는 개방 라벨 확장 시험인 TEMPO-4의 중간 데이터도 포함되어 있습니다.
AbbVie (NYSE:ABBV) a soumis à la FDA une Demande de Nouveau Médicament (NDA) pour le tavapadon, un traitement oral innovant une fois par jour pour la maladie de Parkinson. la soumission est soutenue par les résultats positifs du programme clinique de phase 3 TEMPO, qui ont démontré une efficacité significative dans plusieurs essais.
Le programme TEMPO comprenait trois essais de phase 3 : TEMPO-1 et TEMPO-2 ont montré une amélioration statistiquement significative des scores MDS-UPDRS, parties II et III, chez les patients atteint de Parkinson à un stade précoce, tandis que TEMPO-3 a démontré une augmentation du temps en état « on » chez les patients utilisant tavapadon en traitement d’appoint à la Levodopa. La soumission inclut également des données intermédiaires de l’essai en extension ouverte TEMPO-4.
AbbVie (NYSE:ABBV) hat bei der FDA einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) für tavapadon gestellt, eine neuartige, einmal täglich einzunehmende orale Behandlung der Parkinson-Krankheit. Die Einreichung wird durch positive Ergebnisse des Phase-3-TEMPO-Programms gestützt, das in mehreren Studien eine signifikante Wirksamkeit gezeigt hat.
Das TEMPO-Programm umfasste drei Phase-3-Studien: TEMPO-1 und TEMPO-2 zeigten bei früh erkrankten Parkinson-Patienten eine statistisch signifikante Verbesserung der MDS-UPDRS-Teile II und III, während TEMPO-3 eine verlängerte „On“-Zeit bei der Verwendung von Tavapadon als zusätzliches Therapiegerät zur Levodopa demonstrierte. Die Einreichung enthält zudem Zwischendaten aus der offenen Erweiterungsstudie TEMPO-4.
أبفي (NYSE:ABBV) قد قدمت إلى إدارة الغذاء والدواء الأمريكية (FDA) طلب دواء جديد (NDA) لـ تافابادون، وهو علاج فموي جديد مرة واحدة يوميًا لمرض باركنسون. الدعم للطلب من خلال نتائج إيجابية من برنامج TEMPO العلاجي للمرحلة الثالثة، الذي أظهر فاعلية كبيرة عبر عدة تجارب.
شمل برنامج TEMPO ثلاث تجارب من المرحلة الثالثة: TEMPO-1 و TEMPO-2 أظهرت تحسنًا ذا دلالة إحصائية في درجات MDS-UPDRS الجزءين II و III لدى مرضى باركنسون المبكر، بينما TEMPO-3 أظهر زيادة في الوقت المصاحب للحالة “on” لدى المرضى الذين يستخدمون tavapadon كعلاج مساعد للليفودوبا. كما تتضمن العريضة بيانات وسيطة من تجربة TEMPO-4 مفتوحة المعاينة.
AbbVie（NYSE:ABBV） 已向 FDA 提交新药上市申请（NDA），用于 tavapadon，这是一种每日一次的创新口服治疗帕金森病的药物。该申请得到了 Phase 3 TEMPO 计划积极结果的支持，显示在多项试验中具有显著疗效。
TEMPO 计划包含三项 Phase 3 试验：TEMPO-1 与 TEMPO-2在早期帕金森患者中显示 MDS-UPDRS II、III 评分的统计学显著改善，而 TEMPO-3 在将 tavapadon 作为左旋多巴的辅助治疗时，显示“on”时间增加。提交材料还包括 TEMPO-4 开放标签扩展试验的中期数据。
- Demonstrated statistically significant improvement in MDS-UPDRS Parts II and III scores
- Showed increased 'on' time when used with levodopa
- Novel once-daily oral treatment option for broader patient accessibility
- Potential to enhance AbbVie's leadership position in Parkinson's disease treatment
- None.
Insights
AbbVie's FDA submission for tavapadon marks a significant step forward for Parkinson's disease treatment with promising Phase 3 results.
AbbVie's New Drug Application (NDA) submission for tavapadon represents a significant advancement in Parkinson's disease treatment. This novel selective dopamine D1/D5 receptor partial agonist demonstrated statistically significant improvements in key metrics across three Phase 3 trials. The TEMPO-1 and TEMPO-2 trials showed measurable symptomatic improvement in early-stage patients via the MDS-UPDRS scale, while TEMPO-3 demonstrated increased "on" time (symptom control without dyskinesia) in more advanced patients using tavapadon as an adjunctive therapy to levodopa.
What makes tavapadon particularly noteworthy is its novel mechanism of action targeting D1/D5 receptors, differentiating it from existing therapies that primarily target D2 receptors. This represents a mechanistically distinct approach to managing Parkinson's symptoms. Additionally, its once-daily oral administration could offer significant convenience advantages over existing treatment regimens that often require multiple daily doses.
For AbbVie, this submission strengthens their neuroscience portfolio and could bolster their position in the Parkinson's market, which affects approximately 10 million people worldwide. The company appears to be executing a strategic expansion in this therapeutic area, where unmet needs remain substantial despite existing treatments. With successful Phase 3 trials across different Parkinson's populations, tavapadon appears well-positioned for potential approval, though the FDA review process typically takes 10-12 months for standard reviews.
- Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum
- Positive results across all three Phase 3 TEMPO trials reinforce the potential of tavapadon, a novel selective dopamine D1/D5 receptor partial agonist, in Parkinson's disease
- If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option
The submission is based on results from the TEMPO clinical development program that evaluated the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population. This includes two Phase 3 trials (TEMPO-1 and TEMPO-2) in early Parkinson's disease, and one Phase 3 trial (TEMPO-3) with tavapadon as adjunctive to levodopa in patients experiencing motor fluctuations. TEMPO-1 and TEMPO-2 demonstrated that patients experienced a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.1 TEMPO-3 demonstrated that patients experienced more "on" time, referring to the period when symptoms were well controlled without dyskinesia or involuntary movements.1 The submission is also based on an interim data cut from TEMPO-4, an open-label extension (OLE) trial to assess the long-term clinical benefit of tavapadon.1
"For many people living with Parkinson's disease, today's oral standard of care isn't effective enough to manage symptoms," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We recognize the physical and mental impact that Parkinson's disease can cause and are committed to providing next-generation treatment options that will help individuals regain motor control and independence at all stages of this challenging disease."
About the TEMPO Clinical Development Program
The submission is supported by results from three placebo-controlled studies: TEMPO-1 and -2 enrolled patients with early Parkinson's disease (with or without an MAO-B inhibitor) and TEMPO-3 enrolled patients who are on fixed-dose levodopa and had motor fluctuations. An open-label extension study (TEMPO-4) is ongoing to assess the long-term safety and efficacy of tavapadon through 58 weeks of treatment. TEMPO-4 enrolled patients who completed participation in TEMPO-1 through 3, as well as patients on stable doses of levodopa who had not been in prior TEMPO trials.
TEMPO-1 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of two fixed doses of tavapadon in early Parkinson's disease. The primary endpoint was the change from baseline in the MDS-UPDRS Parts II and III combined score. Key secondary endpoints included change from baseline in the MDS-UPDRS Parts II score and percentage of responders with "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC). A total of 529 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease and had disease duration (from time of diagnosis) of less than three years. Patients were randomized to receive tavapadon titrated to 5 milligrams, tavapadon titrated to 15 milligrams or placebo, orally and once daily.
TEMPO-2 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of flexible doses of tavapadon (5-15 mg QD) in early Parkinson's disease. The primary endpoint was the change from baseline in the MDS-UPDRS Parts II and III combined score. Key secondary endpoints included change from baseline in the MDS-UPDRS Parts II score and percentage of responders with "much improved" or "very much improved" on the PGIC. A total of 304 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease and had disease duration (from time of diagnosis) of less than three years. Patients were randomized to receive tavapadon 5-15 mg QD or placebo, orally and once daily.
TEMPO-3 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial to evaluate the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to LD for advanced Parkinson's disease. Patients were provided with a home diary to assess their motor function status (Hauser diary). The primary endpoint was change from baseline in the total "on" time without troublesome dyskinesia based on the two-day average of the self-completed Hauser diary. Secondary endpoints included change from baseline in total daily "off" time, change from baseline in total "on" and "off" time at earlier timepoints in the trial, and change from baseline in the MDS-UPDRS Part I, II and III scores. A total of 507 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease, were experiencing motor fluctuations and were on a stable dose of LD for at least four weeks prior to screening. Patients were randomized to receive either tavapadon adjunctive to LD, tavapadon titrated to 5-15 milligrams, or placebo and LD, orally and once daily.
The majority of adverse events were non-serious and mild or moderate in severity across TEMPO-1 through 3.1 The incidence of SAEs and deaths were low and comparable between placebo and tavapadon groups.1 The most common adverse reactions reported in ≥
More information on the studies can be found on www.clinicaltrials.gov:
TEMPO-1: NCT04201093
TEMPO-2: NCT04223193
TEMPO-3: NCT04542499
TEMPO-4: NCT04760769
About Parkinson's Disease
More than 11 million people worldwide are living with Parkinson's disease,2 a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.3 The motor symptoms of Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in the brain are lost, and symptoms continue to worsen slowly over the course of time.4 As Parkinson's disease progresses, patients experience complications, including motor and non-motor fluctuations and dyskinesia. Patients report switching from an "on" state (when symptoms are generally well controlled) to an "off" state, during which symptoms such as tremor and stiffness may reappear and patients have more difficulty moving.5 Patients with advanced Parkinson's disease may also experience dyskinesia (involuntary movements) which can significantly hinder daily activities.5 While there is no known cure for the disease, there are treatments available to help reduce symptoms.4
About Tavapadon
Tavapadon is an investigational, novel selective D1/D5 receptor partial agonist that was studied as a once-daily oral medicine for Parkinson's disease for use both with and without levodopa. Tavapadon is not approved by any health regulatory authority.
About AbbVie in Neuroscience
At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit www.abbvie.com.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care — and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Follow @AbbVie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Contact(s):
Kayla Azzato
+1 (224) 355-5243
Kayla.azzato@abbvie.com
Global Media:
Amber Landis
+1 (231) 557-6596
Amber.landis@abbvie.com
Investors:
Liz Shea
+1 (847) 935-2211
Liz.shea@abbvie.com
References
1 AbbVie. Data on file ABVRRTI79943.
2 Statistics. Parkinson's Foundation. Available at: https://www.parkinson.org/understanding-parkinsons/statistics. Accessed August 27, 2025.
3 About Parkinson's: Parkinson's 101. The Michael J. Fox Foundation for Parkinson's Research. Available at: https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php. Accessed August 27, 2025.
4 Parkinson's Disease: Hope Through Research. National Institute of Neurological Disorders and Stroke. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research. Accessed August 27, 2025.
5 "Off" Time in Parkinson's Disease. The Michael J. Fox Foundation for Parkinson's Research. Available at: https://www.michaeljfox.org/time-parkinsons-disease. Accessed August 27, 2025.
US-TAV-250006
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SOURCE AbbVie
FAQ
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