Evoke Pharma said that it has received a multi-disciplinary review letter from the FDA regarding its NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis in adult women. According to Evoke, the letter expressed concerns with quality control and reproducibility related to the delivery device, insufficient data supporting differences in efficacy based on sex, and the fact that the Cmax data are outside BE parameters for abbreviated NDAs.
The company submitted the 505(b)(2) NDA in June 2018, and the FDA accepted the application in August 2018 with a PDUFA date of April 1, 2019. Evoke says that its response will “allow time for potential FDA review prior to the PDUFA date,” but approval by that date is now “uncertain.”
Evoke Pharma CEO Dave Gonyer commented, “We were disappointed by this FDA notification and are in the process of evaluating and addressing FDA’s comments. We remain focused on seeking approval for Gimoti to provide patients with an effective treatment that bypasses the stomach where oral medications are known to be erratically absorbed. Predictably delivered therapeutic options for patients that suffer from gastroparesis remains of high interest to the company and an important need for physicians and patients that suffer from gastroparesis.”
Read the Evoke Pharma press release.
