AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease

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Sep 26, 2025, 08:45 ET

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

NORTH CHICAGO, Ill., Sept. 26, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease.

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 ≥10% of patients were nausea, headache and dizziness for Parkinson's disease patients without levodopa, and nausea and dyskinesia for patients on adjunctive therapy with levodopa.¹

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.

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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):
U.S. Media:
Kayla Azzato
+1 (224) 355-5243
[email protected]

Global Media:
Amber Landis
+1 (231) 557-6596
[email protected]

Investors:
Liz Shea
+1 (847) 935-2211
[email protected]

References

¹AbbVie. 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.