AbbVie has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist being studied as a once-daily oral treatment for Parkinson’s disease, according to the company.
The submission is backed by data from the TEMPO clinical development program, which comprises three Phase 3 trials: TEMPO-1 and TEMPO-2 in early Parkinson’s disease, and TEMPO-3 assessing tavapadon as adjunctive therapy to levodopa in patients experiencing motor fluctuations. An ongoing open-label extension study, TEMPO-4, provided interim long-term data, AbbVie said.
AbbVie claims that in TEMPO-1 and TEMPO-2, tavapadon yielded statistically significant improvements from baseline on the combined MDS-UPDRS Parts II and III scores at 26 weeks. In TEMPO-3, the company says patients achieved increased “on” time without troublesome dyskinesia.
Safety findings across the trials reportedly showed mostly non-serious, mild or moderate adverse events, with serious adverse events and deaths at low incidence rates comparable to placebo. The most common reactions in participants not using levodopa included nausea, headache and dizziness, while those on adjunctive therapy most frequently reported nausea and dyskinesia.
If approved, tavapadon would be AbbVie’s oral treatment offering across Parkinson’s stages. The drug is not yet approved by any regulatory authority, the company noted.
