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Edge Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational product EG-1962 for the treatment of subarachnoid hemorrhage (SAH).
“The FDA Fast Track designation builds upon the orphan drug designations EG-1962 received from both the FDA and European Commission last year, and provides us with even more momentum to address the significant unmet medical needs in the treatment of aneurysmal subarachnoid hemorrhage (aSAH), also known as a ruptured brain aneurysm. We look forward to working closely with the regulatory authorities to rapidly advance the availability of EG-1962 for patients that suffer this life-threatening and catastrophic event.” said Brian A. Leuthner, Edge’s Chief Executive Officer.
Edge expects to begin enrollment in mid-2016 in NEWTON 2, a pivotal Phase 3 multi-center, multi-national, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of EG-1962 versus the standard of care, oral nimodipine, in adults with aSAH. Patients will be enrolled in North America, Europe, Israel and Australasia.
