The US Food and Drug Administration approved tavapadon (Juvmo) for the treatment of adults with Parkinson disease, according to an AbbVie press release. 

The approval was supported by the phase 3 TEMPO clinical trial program, which evaluated tavapadon in patients with early Parkinson disease who were not receiving oral levodopa and as an adjunct to oral levodopa in patients with motor fluctuations.

In TEMPO-1, tavapadon improved activities of daily living at week 26 compared with placebo, as measured by Part II of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Scores decreased by 1.6 points with tavapadon 5 mg and 1.7 points with tavapadon 15 mg, compared with an increase of 0.9 points with placebo. Combined Part II and III scores decreased by 9.7 and 10.2 points with the 5-mg and 15-mg doses, respectively, compared with an increase of 1.8 points with placebo.

In TEMPO-2, Part II scores decreased by 1.5 points with tavapadon 5 to 15 mg at week 26, compared with no change with placebo. Combined Part II and III scores decreased by 10.3 points with tavapadon compared with 1.2 points with placebo.

In TEMPO-3, which evaluated tavapadon as an adjunct to oral levodopa in patients with motor fluctuations, daily “on” time without troublesome dyskinesia increased by 1.7 hours with tavapadon plus oral levodopa at week 26 compared with 0.6 hours with placebo plus oral levodopa. Daily “off” time decreased by 1.9 hours and 0.9 hours, respectively.

Most treatment-emergent adverse events were classified as mild or moderate and were nonserious. Among patients receiving tavapadon without oral levodopa, events reported in at least 5% included nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety. Among those receiving tavapadon plus oral levodopa, events reported in at least 5% included nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension.

AbbVie expects tavapadon to become available in the US in October 2026.

Source: Abbvie