•Gimoti™: Novel nasal delivery of metoclopramide for the symptomatic relief of acute and recurrent diabetic gastroparesis in women
•Large market opportunity:~12-16M patients with symptoms (80% women); ~2-3M currently treated in US given limited efficacy from few available treatment options
•Only one FDA-approved therapy for gastroparesis: Metoclopramide (oral & IV) still has ~4M prescriptions of the oral medication prescribed annually
•Positive data from pivotal comparative exposure PK study: Gimoti demonstrated AUC equivalence
•Estimated $3-4B prescription market
•Resubmission of 505(b)(2) NDA expected Q4 2019
If approved, Gimoti would be the first non-oral pharmacotherapy for gastroparesis approved in 40 years; metoclopramide is currently available in oral and injectable formulations.
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