Evoke Pharma said that it has received minutes from a July 25, 2019 Type A meeting with the FDA and that the company now plans to resubmit its NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis in the fourth quarter of 2019. The company initially submitted the NDA in June 2018; in April 2019, the agency issued a CRL in response to the application.
According to Evoke, the July meeting focused on issues of concern to the FDA including a “root cause analysis of low drug exposure in the comparative bioavailability study and additional product quality/device quality control testing.” The company said that it would include the root cause analysis, data from a 3-month stability data from commercial scale batches, and analysis of nasal spray pump performance characteristics in the resubmission package.
Evoke Pharma President and CEO David A. Gonyer said, “We are very pleased with the outcome of our meeting with FDA and appreciate their thoughtful approach in considering the totality of the data from our previously submitted NDA, along with a root cause analysis summary and additional quality data that will be referenced in our planned resubmission. We now have the clarity required to resubmit our Gimoti NDA in the fourth quarter of 2019, and we believe we have sufficient funds to support our operations into the second quarter of 2020.”
Read the Evoke Pharma press release.
