Grace Therapeutics, a late-stage biopharmaceutical company, announced positive feedback from the FDA regarding its planned New Drug Application (NDA) for GTx-104. GTx-104 is a novel intravenous formulation of nimodipine, designed to treat aneurysmal subarachnoid hemorrhage (aSAH), a rare type of stroke. The FDA indicated the current data package for GTx-104 appears sufficient for NDA submission, which Grace Therapeutics anticipates filing in Q2 2025.
This development is potentially crucial for aSAH patients, who currently rely on oral nimodipine, a medication often problematic due to the patients’ critical condition and frequent swallowing difficulties. GTx-104’s intravenous delivery could bypass these issues, ensuring consistent medication delivery and potentially improving patient outcomes. Furthermore, positive results from the Phase 3 STRIVE-ON trial suggest GTx-104 may reduce the incidence of hypotension, a serious side effect of nimodipine, and improve functional recovery. This could lead to shorter ICU stays and reduced healthcare costs.
The Phase 3 STRIVE-ON trial compared GTx-104 with oral nimodipine in aSAH patients. The results indicated a 19% reduction in clinically significant hypotension among patients receiving GTx-104. Additionally, a significantly higher percentage of patients receiving GTx-104 achieved the target dose intensity compared to those receiving the oral formulation. The trial also observed better functional recovery rates at 90 days and fewer ICU readmissions and ventilator days in the GTx-104 group. While there were more deaths in the GTx-104 arm, these were attributed to the underlying disease severity and not the treatment.
The positive FDA feedback and upcoming NDA submission represent a significant step towards potential approval for GTx-104. If approved, GTx-104 could become the first new treatment option for aSAH in nearly four decades, offering a much-needed alternative to oral nimodipine and potentially improving the lives of thousands of patients affected by this severe condition. This would also solidify Grace Therapeutics’ position in the rare disease market and open up opportunities for further research and development in this area.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
