AbbVie’s application to the FDA for its selective dopamine D1/D5 receptor partial agonist is supported by data from the phase 3 TEMPO study program.
AbbVie has submitted a new drug application (NDA) to the FDA for tavapadon, its investigational selective dopamine D1/D5 receptor partial agonist, for the treatment of Parkinson disease (PD).1 The application is supported by data from the phase 3 TEMPO program, which demonstrated symptomatic improvements across multiple clinical trials.2,3
Three randomized, placebo-controlled phase 3 trials—TEMPO-1 (NCT04201093) and TEMPO-2 (NCT04223193), which evaluated tavapadon in early-stage PD; and TEMPO-3 (NCT04542499), which assessed its use as adjunctive therapy to levodopa in patients with motor fluctuations—provided supporting data. Additionally, an interim analysis from TEMPO-4 (NCT04760769), which is an ongoing, open-label extension trial, also contributed to the application.
"As a physician, I see every day how challenging it can be for people living with Parkinson disease despite available therapies. Levodopa remains the foundation of care, but many patients continue to struggle with their symptoms including experiencing motor fluctuations that interfere with independence and quality of life," Cindy Zadikoff, MD, MSc, the senior medical director of Clinical Development Neuroscience at AbbVie, told NeurologyLive. "If approved, tavapadon would provide movement disorder specialists with a next-generation treatment option with an entirely new mechanism of action to help patients with Parkinson disease stay more active and independent as the disease progresses."
Roopal Thakkar, MD, the executive vice president of research and development and chief scientific officer at AbbVie, echoed that sentiment in a statement,1 adding that, "We recognize the physical and mental impact that Parkinson 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."
The TEMPO-3 trial was the first to report out data, with Cerevel Therapeutics—which was later acquired by AbbVie—announcing the primary end point was met in April 2024.2 All told, data showed that when used as adjunctive to levodopa,
The TEMPO-1 trial assessed the efficacy and safety of 2 fixed doses of tavapadon (5 mg and 15 mg) as a monotherapy in a population of 529 adults with PD, aged 40 to 80 years old. Those data were announced by AbbVie in September 2024,3 with
In other Parkinson disease news, a recent trial showed that 3 infusions of stem cells significantly enhanced motor function in patients with Parkinson disease and highlighted the need for further research into these treatment modalities. Investigators noted that additional trials could ensure the consistency and reliability of cell batches.
A few months later, in December 2024, the results of the TEMPO-2 trial were announced by AbbVie.4 Among the 304 participants included, individuals who were treated with
Zadikoff also highlighted a few key secondary findings that stood out from the trial program "because they hint at truly meaningful benefits," she said. "In both the TEMPO-1 and TEMPO-2 monotherapy studies, tavapadon met the key secondary outcome of improvement in the motor aspects of experiences of daily living (MDS-UPDRS Part II)—things like dressing, eating, walking or even brushing teeth. Those are the kinds of changes patients and families notice most."
"These functional and diary-based endpoints resonate with me because they reflect what patients experience in their daily lives," she added.
Zadikoff noted that the ongoing TEMPO-4 trial will continue monitoring these outcomes to assess how these improvements in motor function, daily living, and patient- and clinician-reported outcomes are sustained over a long-term period of time.
Across all 3 TEMPO trials, tavapadon was deemed well-tolerated by study investigators, with low and comparable rates of serious adverse events (SAEs) and deaths between the treatment and placebo arms. Among the most common AEs reported in patients not taking levodopa were nausea, headache, and dizziness; and in those on adjunctive levodopa were nausea and dyskinesia. Most AEs were classified as mild or moderate in severity.
Earlier this year, NeurologyLive hosted an Insights video series featuring Daniel E. Kremens, MD, JD, the vice chair of education and codirector of the Movement Disorders Program in the Department of Neurology at Thomas Jefferson University. Kremens sat down for a conversation about the therapeutic pipeline for PD. In the series, titled
Watch the video below to hear Kremens offer his perspective on the PD pipeline:
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