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Phase 1 study of intranasal diazepam shows positive results

An intranasal formulation of diazepam being developed by Neurelis for the treatment of acute seizures outside of a hospital setting demonstrated 96% bioavailability compared to the only currently approved treatment, a rectal diazepam gel. The intranasal formulaiton, NRL-1, is delivered using a standard spray pump.

Dr. James Wheless, Director of the LeBonheur Comprehensive Epilepsy Program at the University of Tennessee explains, “Currently, the many patients with epilepsy do not have a viable option to help 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.”

NRL-1 uses Aegis Therapeutics’ Intravail transmucosal absorption enhancing technology, and the formulation was developed and manufactured by CRO Particle Sciences. The pharmacokinetic analysis completed during the study showed all values to be comparable to those of Diastat rectal diazepam gel.

Read the Aegis press release.

Read the Particle Sciences press release.

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published on June 23, 2011

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