Thursday, Jazz Pharmaceuticals plc (NASDAQ:JAZZ) released topline results from the Phase 2b trial evaluating the efficacy and safety of suvecaltamide (JZP385), an investigational, highly selective and state-dependent modulator of T-type calcium channels, in adult patients with essential tremor (ET).
The Phase 2b study assessed the efficacy and safety of suvecaltamide in a once-daily oral dose of 10, 20, and 30mg or placebo.
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 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.
The most common treatment-emergent adverse events (TEAEs) were dizziness, headache, paresthesia, diarrhea, and insomnia. These were predominately mild to moderate in severity.
One participant experienced a serious adverse event considered treatment-related by the investigator.
The suvecaltamide Phase 2 proof-of-concept trial for Parkinson's disease tremor is ongoing, and results are expected in the first quarter of 2025.
Price Action: JAZZ shares are down 3.72% at $108.49 at last check Thursday.
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