Evoke Pharma, Inc. announced that it has completed a pre New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company's planned 505(b)(2) NDA for Gimoti.
Prior to the pre-NDA meeting, Evoke submitted an information package describing the proposed content and format of the regulatory, CMC, and non-clinical sections of the Gimoti NDA. The subsequent face-to-face pre-NDA meeting afforded Evoke the opportunity to gain further understanding of the FDA's expectations regarding these key sections of the NDA.
Based on the FDA's response to the information package and the pre-NDA meeting discussion, Evoke believes it now has the information needed to complete these sections of the NDA in a manner that will be acceptable for the FDA's review of the complete package.
"We are pleased to have begun discussions with the Agency regarding our proposed NDA submission for Gimoti utilizing the 505(b)(2) pathway. We had a very productive meeting and this portion of our data package was well-received," Dave Gonyer, R.Ph., President and CEO, stated. "Additionally, it was agreed that Evoke will request to meet with the FDA again in the near future to discuss the clinical data that will comprise the remaining sections of the NDA."
