Jazz Pharmaceuticals Faces Setback in Essential Tremor Drug Trial
Jazz Pharmaceuticals faced a significant hurdle on Thursday when its phase 2b trial for an essential tremor drug failed to meet its primary endpoint. Despite this obstacle, the company noted some numeric improvements and is awaiting additional data from another study before making any final decisions about the program.
The study evaluated three doses of suvecaltamide, a modulator of T-type calcium channels, against a placebo in 420 patients suffering from essential tremor. Essential tremor is one of the most common movement disorders, but finding effective treatments has been challenging, leaving doctors to rely on older medications like the beta-blocker, propranolol.
Background of the Study
Jazz Pharmaceuticals aimed to capture the market by acquiring Cavion for $52.5 million in 2019 and launching the phase 2b study in 2021. However, the recent results have cast doubt on whether this investment will pay off.
The study showed that suvecaltamide was statistically no more effective than placebo on the TETRAS essential tremor assessment scale, causing the trial to miss its primary endpoint. Despite this, Jazz cited trends suggesting that the highest dose of 30 mg was slightly better than placebo. Interestingly, the placebo performed better than expected in the trial.
Future Outlook
In 2022, Jazz began another phase 2 trial of suvecaltamide for treating tremors in Parkinson's disease. The results of this study are crucial and are expected in the first quarter of next year. Rob Iannone, M.D., global head of R&D at Jazz, stated that the company needs more time to evaluate the essential tremor data and will decide on next steps after reviewing the Parkinson's results.
Evaluation Criteria
Kelvin Tan, Chief Medical Officer at Jazz, explained that the company wouldn't only focus on statistical significance. Instead, they will analyze all collected endpoints to determine what makes a clinically relevant impact. This evaluation will guide their decisions regarding the design of a potential phase 3 trial.
Broader Implications
This failure is a notable setback for Jazz, which had high hopes for the phase 2b study forming part of a pivotal development package. The chosen primary endpoint was crucial as it focused on what matters most to patients – activities of daily living, such as the ability to wash, dress, and feed themselves. The trial's outcome suggests that suvecaltamide is no better than placebo in improving these patient-centric results.
Conclusion
While the road ahead for Jazz Pharmaceuticals' essential tremor program remains uncertain, the company is not closing the door just yet. They are putting their hopes on the upcoming Parkinson's disease trial results, which could ultimately determine suvecaltamide's future.
Stay tuned for updates as we monitor how Jazz Pharmaceuticals navigates this challenging phase.
