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Neurelis Announces Positive Results from Phase 1 Pharmacokinetic Study of NRL-01 (intranasal diazepam)
Date:6/14/2011

them deal with seizure emergencies at home, work or in social settings.  They end up with costly emergency room visits and hospital admissions.  The prospect of delivering diazepam intranasally to minimize seizure emergencies outside of the hospital setting is very attractive for physicians, patients and caregivers."

"We are pleased to have reached this important milestone and excited about results previously unseen with intranasal delivery of benzodiazepines," stated David F. Hale, Chairman of Neurelis.   "Neurelis plans to continue to work with leading clinicians and researchers to advance this important therapy for patients who are living with the challenges of epilepsy."

In the coming months, Neurelis plans to discuss the results of this study with the US Food and Drug Administration (FDA)to gain agreement on the next steps in the clinical progress of this product.  Data from the study is being submitted for review at the 2011 American Epilepsy Society Annual Meeting in December.

About NRL-01

NRL-01 (intranasal diazepam) is a proprietary formulation of diazepam delivered via a commercially available nasal sprayer.  It is being developed for the management of patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity. 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% to 40% of these patients are uncontrolled on oral therapy and are at-risk for acute repetitive 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, the only product approved for the treatment of acute repetitive seizures outside of the acute care setting, is a rectally administered formulation of diazepam called Diastat®. &#
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SOURCE Neurelis, Inc.
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