Pharmaceutical company AbbVie 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 included 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.
TEMPO-3 demonstrated that patients experienced more ‘on’ time, referring to the period when symptoms were well controlled without dyskinesia or involuntary movements. The NDA submission was 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.
“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 recognise 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.”
In trials, 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.
Tavapadon is a dopamine agonist, a class of drugs that bind to dopamine receptors and mimic dopamine’s action in the brain. Dopamine is the brain chemical that decreases in Parkinson’s disease, causing motor symptoms to develop. Unlike other dopamine agonists, tavapadon selectively stimulates only two of the five dopamine receptors in the brain. This more focused action may ease Parkinson’s motor symptoms, potentially without the adverse effects that some other dopamine agonists can cause, such as impulse control disorders (like excessive gambling, spending or overeating), leg swelling or excessive daytime sleepiness. It’s important to note that the new drug has not yet been proven to cause fewer side effects, nor has it been directly compared to other dopamine agonists. The idea of fewer side effects is a theory based on how the medication works.
Ongoing Studies
Interim results of the ongoing TEMPO-4 study were presented at the 2025 International Congress of Parkinson’s Disease and Movement Disorders (MDS) Meeting. In this open-label extension study, researchers are evaluating the safety and effectiveness of long-term tavapadon therapy in Parkinson’s. In an open-label extension study, participants from previous clinical trials — in this case, TEMPO-1, TEMPO-2, and TEMPO-3, regardless of whether they received the treatment or placebo — are treated with the study drug for a longer time period to collect data on the longer-term, real-world safety and tolerability of a drug.
Among people who completed more than a year of treatment, tavapadon continued to show that it is generally safe (reported adverse effects included nausea, dizziness, headache, constipation and falls) and effective, with stable, continued motor symptom improvement.
What’s Next for Tavapadon?
If the NDA submission is accepted for review, an update can be expected within 6 to 10 months. If approved, tavapadon would be a new, once-daily oral medication option for people with Parkinson’s — both recently diagnosed and progressing disease
Sources:
AbbVie
