According to Evoke Pharma, the company has resubmitted its 505(b)(2) for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. Evoke originally submitted the NDA for Gimoti in in June 2018 and announced that the FDA had issued a complete response letter to that NDA in April 2019.
The company said that the resubmitted NDA includes new information requested by the FDA, including a root cause analysis and patient data from clinical trials; stability data from commercial scale registration batches; and data comparing performance characteristics for the pump used in the comparative bioavailability study and the one used for commercial scale registration batches.
Evoke Pharma President and CEO David A. Gonyer said, “We are very pleased to have been able to provide the information requested by FDA in the resubmission of the NDA for Gimoti. If approved, we believe Gimoti has the potential to advance the treatment for gastroparesis treatment by delivering the drug nasally, to help avoid problems with GI absorption commonly seen in patients with this disease.”
Read the Evoke Pharma press release.
