Policy & Regulation
Xeris Pharmaceuticals Granted Fast Track Designation by the FDA for Its Novel Concentrated Diazepam Formulation (XP-0863) For Injection
22 October 2020 - - US-based pharmaceutical company Xeris Pharmaceuticals, Inc. (NASDAQ: XERS) was granted Fast Track designation by the Food and Drug Administration for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures, the company said.

Xeris' XP-0863 was previously granted orphan designations both for the treatment of acute repetitive seizures and for the treatment of Dravet Syndrome.

As previously reported, 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.

Diazepam is in a class of medications called benzodiazepines. It works by calming abnormal overactivity in the brain.

Diazepam is used in emergency situations to stop cluster seizures (episodes of increased seizure activity) in people who are already taking medications to control their seizures. Diazepam is only recommended for short-term treatment of seizure attacks.

Uncontrolled seizures can turn into serious (possibly fatal) seizures that do not stop (status epilepticus).

There are over 2.7m people with epilepsy in the United States with approximately 200,000 new patients diagnosed each year.

It is estimated that between 30% and 40% of these patients are uncontrolled on oral therapy and are at risk for acute breakthrough seizures.

Acute repetitive or cluster seizures may occur over a number of hours or days and can include any seizure type. Studies have shown that prolonged or repetitive seizures can cause neurological damage and dramatically increase the risk of changes in neuropsychological function or even death.

Xeris (NASDAQ: XERS) is a specialty pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world.

With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable and infusible therapies, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke.

Its proprietary XeriSol and XeriJect formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous infusion.

With Xeris' technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.
Xeris is headquartered in Chicago, IL.
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