Positive Phase 3 Results for First-in-Class Parkinson's Med

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Positive Phase 3 Results for First-in-Class Parkinson's Med
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An experimental first-in-class oral selective partial D1/D5 dopamine receptor agonist for Parkinson's significantly reduce disease burden in two phase 3 trials.

In the TEMPO-3 trial, topline findings reported earlier this year showed that patients with PD and motor fluctuations receiving once-daily tavapadon as adjunct therapy toenrolled 507 patients aged 40-80 years with PD who had a modified Hoehn and Yahr score of 2, 2.5, or 3 during"on" periods, a good response to levodopa on a minimum stable dose of at least 400 mg/d, and a minimum of 2.5 hours of"off" time on 2 consecutive days during screening.

Patients receiving once-daily adjunctive tavapadon had a significant 1.1-hour increase in the primary outcome of total daily"on" time without troublesome dyskinesias compared with placebo at 27 weeks, based on the two-day average of the self-reported Hauser diary . Modest decreases in supine blood pressure and weight were observed in patients treated with tavapadon, he said.

What distinguishes tavapadon is its tolerability and unique dopamine receptor profile. This profile places tavapadon slightly closer to levodopa than other dopamine agonists in that it has little effect on the D3 receptor, which has been linked to impulse control behavioral disorders, she said. TEMPO-1 is being conducted at 77 sites in the US, Europe, Australia, Israel, and Ukraine in 522 participants who were treatment naive or had received dopaminergic agents for less than 3 months and not within 2 months of baseline.

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