Evoke Receives FDA Conditional Acceptance of Gimoti Brand Name Following NDA Resubmission
May 20, 2020 at 08:30 am
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Evoke Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary brand name, “Gimoti,” for the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis as resubmitted in the 505(b)(2) New Drug Application (NDA). The name Gimoti (pronounced “jye-MOH-tee”) was developed in compliance with FDA’s Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. Based on the development program, which included research with physicians and pharmacists, as well as an international name assessment, the Company believes Gimoti is a proprietary name with strong marketing potential that is also consistent with FDA’s goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use.
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development and commercialization of drugs to treat gastrointestinal (GI) disorders and diseases. The Company operates through the development and commercialization of pharmaceutical products. It is developing its product, Gimoti (metoclopramide) nasal spray, the first and only nasally administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. It developed Gimoti, a dopamine antagonist / mixed 5-HT3 antagonist / 5-HT4 agonist with pro-motility and anti-emetic effects, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. Gimoti is a novel formulation of metoclopramide offering systemic delivery by nasal spray administration. It has developed the nasal formulation of metoclopramide to provide its targeted patient population with acute or recurrent symptoms of diabetic gastroparesis.
EVOKE PHARMA, INC. 
