Clinical Trials & Regulatory

  • Extensive PK studies and clinical trials have been completed by prior sponsor, NASA, in collaboration with Nastech and the US Navy. A New Drug Application (NDA) on a 505(b)2 pathway is being developed for submission to the FDA.

  • Two well-controlled parallel, double-blind phase III trials completed showing efficacy and safety

  • Over 1,000 patients have been dosed, with virtually no SAEs

  • Fast Track designation has been granted by the FDA

  • Work remains on CMC (i.g., stability batches)

               Summary of Intranasal Scopolamine Hydrobromide Gel Studies                   

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