Grace Therapeutics Phase 3 STRIVE-ON Safety Study Meets Primary Goal

(RTTNews) - Grace Therapeutics, Inc. (GRCE), a late-stage biopharma company, Monday said Phase 3 STRIVE-ON safety study met its primary goal.

The STRIVE-ON study was designed to evaluate GTx-104, an injectable formulation of nimodipine, compared with oral nimodipine in patients with aneurysmal Subarachnoid Hemorrhage (aSAH). Patients receiving GTx-104 were observed to have a 19 percent reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine, thus achieving the primary goal.

The company plans to submit new drug application (NDA) for GTx-104 to the Food and Drug Administration (FDA) in the first half of this year.