Jazz Pharmaceuticals’ Essential Tremor Drug Candidate Fails to Meet Primary Endpoint in Phase IIb Trial
1. Trial Failure: Jazz Pharmaceuticals' phase IIb trial of suvecaltamide, a calcium channel modulator, failed to meet its primary endpoint in treating essential tremor patients.
2. Study Details: The trial compared three doses of suvecaltamide to placebo in 420 patients, but the drug was statistically no better than placebo on the TETRAS essential tremor assessment scale.
3. Numeric Improvements: Despite missing the primary endpoint, the study showed numeric improvements favoring the top dose (30 mg) over placebo on primary and key secondary endpoints.
4. Future Plans: Jazz Pharmaceuticals is waiting for data from another study in Parkinson's disease tremor patients before deciding on the next steps for suvecaltamide.
5. Evaluation Criteria: The company will consider factors beyond statistical significance, such as clinically relevant impact, in evaluating the data and planning future trials.