> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Evoke Pharma NDA for Diabetic Gastroparesis Therapy
- URL: https://www.fdaweb.com/evoke-pharma-nda-for-diabetic-gastroparesis-therapy/
- Published: 2018-08-16T12:00:00.000Z
- Updated: 2026-09-15T00:26:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142135

FDA has accepted for review an Evoke Pharma 505(b)(2) NDA for Gimoti, a nasal spray product candidate for relieving symptoms in adult women with acute and recurrent diabetic gastroparesis. The agency has set a user fee target review date of 4/1/2019.

“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,” the company says. An agency communication letter did not indicate that it is planning to hold an advisory committee meeting to discuss the NDA, it adds.

Gastroparesis is described by Evoke as a debilitating, episodic condition that disproportionately affects adult women and is characterized by slow or delayed gastric emptying of the stomach’s contents after meals, often resulting in flares of symptoms that include nausea, vomiting, abdominal pain and bloating. Vomiting and gastric emptying delays can cause unpredictable absorption of food and oral medications, which complicate glucose control and can lead to dehydration and malnutrition, it says.