Jazz Pharmaceuticals’ Phase 2b trial in essential tremor doesn’t meet endpoints

Jazz Pharmaceuticals announced 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 and key secondary endpoint of Clinical Global Impression-Severity 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. The Phase 2 Parkinson’s disease tremor trial is ongoing with results expected 1Q25. Suvecaltamide was well tolerated and the overall safety profile was consistent with previous studies with no new safety signals observed.