The U.S. FDA notified Evoke Pharma Inc. that showing equivalent exposure to the listed drug Reglan in a healthy volunteer pharmacokinetic trial could serve as a portion of a new drug application for Evoke's Gimoti.
Gimoti is Evoke's patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
Upon demonstration of appropriate exposure in the trial, Evoke will submit the pharmacokinetic data and prior clinical studies to the FDA for review in the Gimoti application.
The FDA agreed that no new efficacy or safety study would be required if bioequivalence criteria were met. During review and labeling negotiations, safety and efficacy data from completed Gimoti studies, including the thorough ECG study, may be used to support information included in the Gimoti label.
Evoke's phase 3 data for Gimoti showed statistically significant efficacy compared to placebo for patients with moderate to severe symptoms at baseline in a post-hoc analysis. The moderate to severe population consisted of more than half of the 205 women participating in the trial.
Favorable safety data from the placebo-controlled studies in diabetic gastroparesis patients and the studies in healthy volunteers will support the planned application.