Shots:
- The US FDA has received an NDA for tavapadon (QD, PO) for Parkinson’s disease (PD), supported by P-III (TEMPO-1 & 2) trials in early PD & P-III (TEMPO-3) evaluating adjunctive use with levodopa in pts with motor fluctuations, plus interim data from P-III (TEMPO-4) open label study
- TEMPO-1 (n=529) & TEMPO-2 (n=304) evaluated fixed (5 or 15mg) & flexible (5–15mg) tavapadon vs PBO, respectively in early PD pts (40–80 yrs) for 27wks., while TEMPO-3 (n=507) assessed tavapadon adjunctive to levodopa in advanced PD for 27wks.
- TEMPO-1 & TEMPO-2 showed significant improvement in MDS-UPDRS Parts II & III combined score at Wk. 26, while TEMPO-3 showed pts had increased “on” time with better symptom control & reduced dyskinesia
Ref: AbbVie | Image: AbbVie | Press Release
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