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# AbbVie Reports Positive Parkinson’s Trial Data
- URL: https://www.fdaweb.com/abbvie-reports-positive-parkinsons-trial-data/
- Published: 2024-12-09T12:00:00.000Z
- Updated: 2026-09-14T14:48:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158329

AbbVie is announcing “positive topline results” from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease. The investigational D1/D5 dopamine receptor partial agonist is being evaluated as a once-daily treatment for Parkinson’s. Based on the results, AbbVie says it is on track to submit an NDA next year.

Patients treated with tavapadon, according to the company, experienced a statistically significant reduction (improvement) from baseline compared to placebo in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts 2 and 3 combined score at Week 26\. The trial also met a key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living (MDS-UPDRS Part 2) in both tavapadon dose groups compared to placebo, it adds.

The safety profile observed in the TEMPO-2 trial was consistent with prior clinical trials, AbbVie says, adding that the majority of adverse events reported were mild to moderate in severity.