Xeris Pharmaceuticals, Inc. a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced it was granted Fast Track designation by the Food and Drug Administration (FDA) for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures. Xeris’ XP-0863 was previously granted orphan designations both for the treatment of acute repetitive seizures and for the treatment of Dravet Syndrome.
“The FDA’s Fast Track designation highlights the clear unmet need in treating acute repetitive seizures with the preparations of diazepam available today and highlights our opportunity to dramatically improve care through the introduction of a ready-to-use injection formulation,” said Paul R. Edick, Xeris’ Chairman and Chief Executive Officer. “We are working to identify the right development and commercialization partner who can accelerate our efforts to evaluate and deliver this simple format that could make all the difference in an urgent seizure setting.”
As previously announced, complete results of the Phase 1b study were shared with the US FDA in an End-of-Phase 1 interaction. The FDA provided feedback that Xeris’ drug development program for XP-0863 could advance directly into a Phase 3 registration study in both pediatric and adult patients with epilepsy.