Jazz Pharmaceuticals(US:JAZZ) Prnewswire·2024-06-20 11:45Core Insights - Jazz Pharmaceuticals announced top-line results from the Phase 2b clinical trial evaluating suvecaltamide (JZP385) for essential tremor, which did not achieve statistical significance on the primary endpoint compared to placebo [6][11] - The trial involved 420 participants across four countries and assessed the efficacy and safety of suvecaltamide at doses of 10mg, 20mg, and 30mg [11] - Suvecaltamide was well tolerated, with a safety profile consistent with previous studies, and the most common treatment-emergent adverse events were mild to moderate [7] Phase 2b Trial Details - The trial was a 12-week, multicenter, double-blind, randomized, placebo-controlled study [11] - The primary endpoint was the modified TETRAS composite outcome score, while the key secondary endpoint measured the percentage of participants with a ≥1 point improvement on the CGI-S scale [11] - Numeric improvements were observed at the 30mg dose versus placebo, although not statistically significant [1][6] About Suvecaltamide - Suvecaltamide is a highly selective and state-dependent modulator of T-type calcium channels, which are involved in muscle movement control [3] - The ongoing Phase 2 proof-of-concept trial in Parkinson's disease tremor is expected to provide further insights, with results anticipated in the first quarter of 2025 [11] Company Overview - Jazz Pharmaceuticals is a global biopharmaceutical company focused on developing life-changing medicines for serious diseases with limited therapeutic options [8] - The company has a diverse portfolio, including therapies for sleep disorders, epilepsy, and a growing range of cancer treatments [8]