FDA Fast Track Designation for NRL-1

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Neurelis, Inc. recently announced that the US Food and Drug Administration (FDA) has designated NRL-1 (intranasal diazepam) as a Fast Track Development program for the management of selected, refractory patients with epilepsy, on a stable regimen of anti-epileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizures – also referred to as acute repetitive or cluster seizures. Receiving the designation will allow the company to have prioritized interactions with the FDA as Neurelis completes the clinical development program and prepares for submission of a New Drug Application (NDA) for NRL-1 in the United States. In addition, Fast Track Designation affords the potential for a more timely NDA filing and expedited or priority review of the NDA.  

Jacqueline French, MD, Professor of Neurology at NYU Langone's Comprehensive Epilepsy Center, a Fellow of the American Neurological Association and one of the lead investigators for NRL-1, added, "Presently, there remains an unmet need for epilepsy patients suffering from acute repetitive or cluster seizures. The only approved option currently available requires rectal administration, which can be an issue – especially with adolescent and adult patients.  We are studying NRL-1, whose unique formulation should allow us to deliver a therapeutic dose of diazepam via a well-tolerated nasal spray.  This would allow for rapid treatment of these seizures where they occur — at home, work, school or elsewhere."

Read the full release.