According to Evoke Pharma, the company held a pre‑NDA meeting with the FDA about its intranasal metocopramide for the treatment of diabetic gastroparesis in adult women and now believes that it will be able to complete the CMC and non-clinical sections of its 505(b)(2) NDA in a manner that will be acceptable to the agency.
The company said that, “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.”
Evoke President and CEO Dave Conyer commented, “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. 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.”
Read the Evoke Pharma press release.
