Xeris granted FDA Fast Track Designation for Diazepam injection formulation

The company previously announced that 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. 

There are over 2.7 million 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. 

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).