Evoke Receives FDA Conditional Acceptance of Gimoti Brand Name Following NDA Resubmission

SOLANA BEACH, Calif., May 20, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today 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.

“Receipt of conditional proprietary brand name approval further supports our commercialization strategy,” said Dave Gonyer, R.Ph., President and CEO. “Gimoti’s nasal spray delivery is designed to facilitate drug absorption by allowing Gimoti to bypass the dysfunctional GI track in patients with this disease. We continue to believe Gimoti, if approved, will provide an important new product that has the potential to help treat patients suffering from gastroparesis.”

About Evoke Pharma, Inc.

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.

Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Metoclopramide is currently available only in oral and injectable formulations and is the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.