Xeris Pharmaceuticals Inc (NASDAQ:XERS) Receives Fast Track Designation For XP-0863 From The FDA

Xeris Pharmaceuticals Inc (NASDAQ:XERS) recently announced that XP-0863, its innovative developmental treatment for acute repetitive seizures, received fast track designation from the Food and Drug Administration (FDA).

XP-0863 is a diazepam non-aqueous injection that Xeris has been developing as a therapeutic option for acute repetitive seizures. The pipeline treatment previously received orphan drug designation from the FD as a treatment for Dravet Syndrome and acute repetitive seizures. Therefore, the recently awarded fast track designation adds to the strong profile that the drug has achieved so far.

“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,” stated Xeris CEO, Paul R. Edick.

Mr. Edick also revealed that his company is working towards determining the ideal partner for further development and commercialization of XP-0863. Xeris’ goal is to fast-track its development efforts for the therapy so that the treatment can be made available to seizure patients who need it as fast as possible.

Xeris previously revealed that it provided the complete results of XP-0863’s Phase 1b study to the FDA as part of an End-of-Phase 1 interaction. The FDA’s response to the data was also favorable, and the recommendation provided thereafter was that Xeris could move directly into a Phase 3 registration study of XP-0863. The study will evaluate the treatment’s performance in epilepsy patients and enroll adult and pediatric patients.

Epilepsy statistics

Roughly 2.7 million people have epilepsy in the U.S, and roughly 200,000 cases are discovered each year. Researchers believe that between 30% and 40% of epilepsy patients have been treated with oral medicine, but the treatment has not done much to control the seizures. These patients are also at a high risk of developing acute breakthrough seizures.

Researchers also found that prolonged seizures may lead to neurological damage, causing neuropsychological changes and sometimes even risk death. This is why XP-0863 is such a big deal, especially for patients who urgently need a solution to address their unmet needs.