According to Evoke Pharma, the FDA has issued a complete response letter in response to the company’s NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The PDUFA date for completion of review of the 505(b)(2) NDA submitted by Evoke in June 2018 was April 1, 2019.
In March 2019, Evoke announced that it had received a multidisciplinary review letter from the agency that noted a number of concerns with the application. The company says that the CRL addresses fewer problems than that letter, but the FDA continues to have concerns about some of the data in the pivotal PK study and issues related to the spray droplet size distribution.
Evoke said that the FDA’s questions about the PK study stem from low Cmax in a small percentage of subjects that affected the overall data, and the agency suggested a root cause analysis to determine the source of the variability in the data. The agency also asked for data from registration batches to support the proposed acceptance criteria for spray droplet size distribution.
Evoke Pharma President and CEO Dave Gonyer said, “We believe that the issues cited in the CRL, which were related to concerns over reproducible dose delivery, can be addressed. We look forward to meeting with FDA to gain a full understanding of the agency’s requirements for approval and remain committed to bringing our novel nasal formulation of metoclopramide to patients.”
Read the Evoke Pharma press release.
