SAN DIEGO, April 20, 2011 /PRNewswire/ — 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 rect