Neurelis wins fast track designation from FDA for intranasal diazepam spray

Neurelis, Inc. said today that it won fast track designation from the FDA for its intranasal diazepam spray. The  nasal formulation of diazepam, which is being developed for pediatric and adult epilepsy patients who experience repititive or cluster seizures, is in the final stage of clinical development, according to Neurelis. The company expects to submit a new drug application to the federal watchdog by early 2018. “We are very excited to have received fast track designation status with the FDA,” president & CEO Craig Chambliss said in prepared remarks. “We are looking forward to working with the FDA as we complete our clinical development work,  assemble our NDA submission, and prepare for the commercialization of NRL-1.  We are focused on providing epilepsy patients and health care providers with an effective, well-tolerated, and user-friendly product for the treatment of acute repetitive or cluster seizures.” Get the full story at our sister site, Drug Delivery Business News. The post Neurelis wins fast track designation from FDA for intranasal diazepam spray appeared first on MassDevice.
Source: Mass Device - Category: Medical Equipment Authors: Tags: Drug-Device Combinations Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Clearance Wall Street Beat Neurelis Inc. Source Type: news