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Jump to Key Points The FDA has approved tavapadon (JUVMO, AbbVie) tablets for adults with Parkinson's disease (PD), the first and only selective D1/D5 receptor agonist approved for this indication.
The approval was based on data from three pivotal phase 3 studies in the TEMPO clinical trial program.
As reported by Medscape Medical News, preliminary findings from TEMPO 1 and TEMPO 2 were presented at the American Academy of Neurology 2025 annual meeting.
Among 529 patients in TEMPO 1, those who received the active drug had a significant reduction in combined scores on the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II and Part III at 26 weeks compared to those who received placebo. Similar findings occurred among 304 participants in the TEMPO 2 trial.
- FDA approved tavapadon for adults with PD; first selective D1/D5 agonist.
- TEMPO 1/2: significant MDS-UPDRS II+III improvement vs placebo at 26 weeks.
- TEMPO 3: add-on tavapadon ↑ daily on-time and ↓ off-time with levodopa.
- Common AEs: nausea, dizziness, headache; add-on use also dyskinesia, hallucinations, orthostatic hypotension.
- Open-label data: sustained efficacy to 85 weeks; ICER rated net benefit promising but inconclusive.
Results from TEMPO 3 showed that tavapadon 5-15 mg plus oral levodopa was associated with increased total daily "on" time vs placebo added to oral levodopa at 26 weeks (P < .0001) and with significantly decreased total daily "off" time (P = .0006). Preliminary findings from this study were reported by Medscape Medical News from the 2024 International Congress of Parkinson's Disease and Movement Disorders.
"Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson's community," Brian Fiske, PhD, chief scientist of The Michael J. Fox Foundation for Parkinson's Research, said in a release.
Bridges a Gap?
Conventional dopamine agonists long used in PD care mostly target D2/D3 receptors, and their use "may be limited by tolerability concerns," the company noted in the release. Tavapadon, on the other hand, was created to selectively target D1/D5 receptors for the management of PD-related motor symptoms.
This type of targeting "addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs," Huber Fernandez, MD, global principal TEMPO trial investigator and from neurology professor at the Cleveland Clinic Lerner College of Medicine, added in the statement.
In addition to the efficacy outcomes shown in the TEMPO-1, 2, and 3 trials, the study drug showed sustained efficacy up to 85 weeks during an open-label extension period in TEMPO-4, with treatment-emergent adverse events (AEs) deemed nonserous and mild or moderate.
For patients receiving tavapadon only, the most common AEs were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety. For those taking tavapadon plus oral levodopa, the most common were nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension.
The newly approved oral tablets will be available at doses of 5, 10, and 15 mg, or in a titration pack at 0.25 and 1 mg.
In a feature story by Medscape Medical News published earlier this month, Fernandez noted that it has been decades since a PD drug has been released that could be effective from early to advanced disease.
"Tavapadon could give us another option that bridges that gap," he said.
However, an independent draft evidence review by the Institute for Clinical and Economic Review released in March rated tavapadon's net health benefit as "promising but inconclusive." It also cautioned that 26-week trials are probably too brief to draw firm conclusions about such possible AEs as impulse-control behaviors.
