Neurelis completes dosing in intranasal diazepam formulation study

Neurelis, Inc. today announced the completion of subject dosing in a randomized crossover study assessing diazepam pharmacokinetics and bioavailability after administration of two proprietary formulations of intranasal diazepam and intravenous injection. Through the collaboration with the University of Minnesota and James Cloyd, PharmD; Neurelis has partnered with the leading experts in clinical research of the nasal delivery of benzodiazepines.  Results from this important study are expected in June.

"We are pleased to work with Dr. Cloyd and the University of Minnesota to complete dosing in the first human trial of our unique nasally administered formulations of diazepam," stated David Hale, Chairman.  "Neurelis has incorporated proprietary technologies to develop intranasal diazepam formulations that can be delivered with a standard sprayer to patients experiencing acute breakthrough seizures.  These intranasal product formulations seek to address the need for a convenient and effective therapy that could help reduce acute breakthrough seizures and avoid the need for costly emergency room visits."

Intranasal diazepam is being developed for the management of patients who require intermittent use of diazepam to control bouts of acute breakthrough seizure activity. There are over 2.7 million people with epilepsy in the United States.  It is estimated that between 30% to 40% of these patients are uncontrolled on oral therapy and are at-risk for acute breakthrough seizures.  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.

Presently, there is only one product approved for the treatment of acute repetitive seizures outside of the acute care setting, which is a rectally administered formulation of diazepam called Diastat®.  Because of its rectal mode of administration, Diastat® is primarily used in younger pediatric patients.  The majority of patients with acute breakthrough seizures, however, are seen in emergency rooms and may have an associated admission to the hospital, contributing to the estimated $15 billion annual economic burden.  Intranasal diazepam would provide a convenient alternative to either rectal administration or the need to visit the emergency room for intravenous administration of drugs.