The Food and Drug Administration (FDA) has accepted for review the New Drug Application for Gimoti (Evoke Pharma), an investigational treatment for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.

Gimoti is a nasal spray formulation of metoclopramide which is currently only available in oral and intravenous forms. The NDA includes results from a Phase 3 study which showed significant treatment benefit with Gimoti in patients with moderate to severe symptoms. In addition, results from a pharmacokinetics trial demonstrated bioequivalence to metoclopramide tablets.

The FDA has set a Prescription Drug User Fee Act target date of April 1, 2019. According to the Company, Gimoti could potentially be the first non-oral drug therapy for diabetic gastroparesis to be approved in 40 years. “We believe that Gimoti holds the potential to significantly improve the quality of life for these patients, particularly those who fail to achieve adequate relief from current oral therapy, and often face debilitating symptom flares of nausea, vomiting and abdominal pain,” said Dave Gonyer, President and CEO of Evoke Pharma.

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