Novel Injectable Nimodipine Under Review for Aneurysmal Subarachnoid Hemorrhage

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for GTx-104 for the treatment of aneurysmal subarachnoid hemorrhage (aSAH).

In patients with aSAH, oral nimodipine, a dihydropyridine calcium channel blocker, is considered the standard of care to prevent delayed cerebral ischemia. GTx-104 is a novel, intravenous formulation of nimodipine that has the potential to better manage hypotension in aSAH, in addition to reducing the potential for food effects, drug-drug interactions, and dosing errors that may occur with the oral formulation. Currently, nimodipine is only available as an oral formulation administered enterally (eg, oral, nastrogastric tube, gastric tube route). 

The randomized, open-label, phase 3 STRIVE-ON safety trial (ClinicalTrials.gov Identifier: NCT05995405) compared GTx-104 (n=50) with oral nimodipine (n=52) in patients hospitalized with aSAH. The primary endpoint was the number of patients with at least 1 episode of clinically significant hypotension (hypotension event requiring medical treatment) reasonably considered to be caused by the drug, according to the Endpoint Adjudication Committee. 

Findings showed 28% of patients in the GTx-104 group and 35% of those in the oral nimodipine group experienced at least 1 episode of clinically significant hypotension, corresponding to a 19% reduction with the IV formulation. Additionally, 54% of GTx-104-treated patients had a relative dose intensity of 95% or higher of the prescribed dose vs 8% of those treated with oral nimodipine. 

Results also showed more patients on GTx-104 had better functional outcomes at day 90 vs those on oral nimodipine (29% relative increase). Notably, fewer intensive care unit (ICU) readmissions, ICU days and ventilator days were reported in the GTx-104 arm vs the oral nimodipine arm. 

As for safety, adverse events were similar between both arms, with no new safety issues being observed. There were 8 deaths in the GTx-104 group and 4 deaths in the oral nimodipine group; however, no deaths were related to the treatments themselves. 

“FDA acceptance for review of our NDA for GTx-104 for the treatment of aSAH is another significant milestone for Grace Therapeutics, further demonstrating our ability to execute as we continue to advance this important innovation for aSAH patients,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “Our NDA is supported by a robust data package including positive results from our STRIVE-ON trial, which provide support for improved clinical outcomes in aSAH patients and both medical and pharmacoeconomic evidence of the potential benefit of GTx-104 in the treatment of aSAH.”

A Prescription Drug User Fee Act target date of April 23, 2026 has been set for the application.

This article originally appeared on MPR