Evoke Pharma announced results from the Phase 3 trial of Gimoti, an investigational treatment intended to relieve symptoms related to acute and recurrent diabetic gastroparesis in women.
Gimoti is a nasal spray formulation of metoclopramide which is currently only available in oral and intravenous forms. The trial enrolled 205 patients with symptomatic diabetic gastroparesis, 105 of whom had moderate to severe symptoms of recurrent diabetic gastroparesis. The trial lasted 4 weeks and was double-blinded with patients randomized 1:1 to receive either Gimoti or placebo in a single nasal spray 4 times daily; 30 minutes before meals and at bedtime.
Results showed that the primary efficacy endpoint of change from baseline to week 4 was not statistically met (P=0.881), although a significant treatment benefit was seen in patients with moderate to severe symptoms (P<0.05). Safety data from this trial were consistent with favorable results from previous Gimoti studies.
The data from the trial is expected to be used in a forthcoming new drug application to be submitted to the Food and Drug Administration. “We are very pleased that Digestive Disease Week [where the results were presented] accepted this data for presentation as we believe it is among the most up-to‑the-minute and novel GI developments that will impact research and the care of patients,” said Marilyn R. Carlson, DMD, MD, and CMO of Evoke Pharma.
For more information visit Evokepharma.com.