Evoke Pharma has announced that a Phase 3 trial of EVK-001 intranasal metoclopramide in 205 female diabetic gastroparesis patients failed to achieve its primary endpoint, which was improvement of symptoms at Week 4. EVK-001 and placebo treatment both produced similar improvement at Week 4. Results from a Phase 2b study announced in January 2014 had shown superior efficacy of EVK-001 compared to oral metoclopramide.
In February 2015, Evoke had announced that enrollment in the trial was slower than expected, delaying the Phase 3 development program.
Evoke President and CEO Dave Gonyer commented, “The topline results are unexpected and an anomaly, given that metoclopramide has been approved and used for treating diabetic gastroparesis for more than 35 years. Additionally, EVK-001 provides predictable absorption of metoclopramide as seen in our prior trials. We continue to believe that EVK-001 is a promising treatment option for patients who currently rely on oral drugs to treat their symptoms of gastroparesis. Our analysis will continue as the remainder of the data become available and an update will be provided when we have more clarity on our steps ahead.”
Read the Evoke Pharma press release.
