Jazz Pharma Says Phase 2b Trial Of Suvecaltamide In Essential Tremor Fails To Meet Primary Endpoint
(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) announced Thursday top-line results from the Phase 2b clinical trial evaluating the efficacy and safety of suvecaltamide, an investigational, highly selective and state-dependent modulator of T-type calcium channels, in adult patients with essential tremor (ET).
Suvecaltamide did not achieve statistical significance at 30mg versus placebo on the primary endpoint of change from baseline to week 12 on the Essential Tremor Rating Assessment Scale (TETRAS) modified composite outcome score and key secondary endpoint of Clinical Global Impression-Severity (CGI-S) scale.
While not statistically significant, numeric improvements were observed on the primary endpoint and key secondary endpoint at 30mg versus placebo. The improvement in placebo from baseline to week 12 also exceeded the Company's expectations and was higher than what was observed for placebo in the prior T-CALM trial of suvecaltamide.
Suvecaltamide was well tolerated and the overall safety profile was consistent with previous studies with no new safety signals observed.
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