Evoke Pharma has announced that the FDA has accepted the company’s 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, which Evoke submitted in June 2018. The PDUFA date has been set for April 1, 2019.
In a separate letter, the agency also informed Evoke that it had conditionally accepted the proprietary brand name “Gimoti.”
According to the company, the filing communication from the FDA did not mention any planned meeting by an advisory committee to discuss the application.
Evoke President and CEO Dave Gonyer said, “We are pleased with FDA’s acceptance of our NDA for filing, which reaffirms our commitment to bringing this novel non-oral drug product to adult women who suffer from diabetic gastroparesis. 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.”
Read the Evoke Pharma press release.
