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Neurelis Announces FDA Allowance of IND Application for NRL-1, a Novel Intranasal Diazepam Formulation
Date:2/6/2012

s 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, the only product approved for the treatment of acute repetitive seizures outside of the hospital setting, is a rectally administered formulation of diazepam called Diastat®.  Because of its rectal mode of administration, Diastat® has been primarily relegated to use in younger pediatric patients (usually less than 10 years of age).  The majority of patients with acute repetitive seizures; however, are currently seen in emergency rooms and treated with intravenous benzodiazepines.  Most of these patients are admitted to the hospital.  This represents a significant component of the estimated $15 billion annual economic burden on the system to treat epilepsy in the U.S.  Intranasal diazepam would provide a more convenient alternative to either rectal administration of Diastat® or the need to visit the emergency room for intravenous administration of drugs.

About Neurelis

Neurelis, Inc. is a San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system ("CNS") market.  Neurelis leverages expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates to address significant unmet medical needs.

Contact: David F. Hale
858-756-2480
Email: salaimo@neurelis.com

 

 

 


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