Xeris Pharma gets US FDA fast track designation for diazepam non-aqueous injection to treat acute repetitive seizures

Xeris Pharmaceuticals 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. We are working to identify the right development and commercialisation partner who can accelerate our efforts to evaluate and deliver this simple format that could make all the difference in an urgent seizure setting,” said Paul R Edick, Chairman and CEO, Xeris.

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 paediatric and adult patients with epilepsy.