Evoke Pharma, Inc., a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, announced that the US Food and Drug Administration (FDA) has conditionally accepted the proprietary brand name, "Gimoti," for the Company's product candidate, EVK-001 (metoclopramide nasal spray). A request for proprietary name review for Gimoti will be included if and when Evoke submits a New Drug Application (NDA) for the product candidate.
The name Gimoti (pronounced "jye-MOH-tee") was developed in compliance with the FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names (issued in February 2010). The development program, which included research with physicians and pharmacists, as well as an international name assessment, confirmed Gimoti is a proprietary name with strong marketing potential that is also consistent with the FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use.
"The naming of EVK-001 as Gimoti further demonstrates our belief that there is value in pursuing the approval of our product candidate for the treatment of diabetic gastroparesis in women. We are pleased to have the FDA's conditional approval of this brand name," said Dave Gonyer, R.Ph., President and CEO.
"As we consider our options to move forward with Gimoti, we are analyzing data from our recently completed Phase 3 trial as well as additional trials to assess continued development opportunities for this product candidate and all possible submission strategies. These efforts will be supported by the recent financing we successfully completed."
