Evoke Pharma has published a Phase 2b study demonstrating superior efficacy of intranasal metoclopramide compared to oral metoclopramide for the management of diabetic gastroparesis symptoms. The study appears in an upcoming issue of Neurogastroenterology & Motility and appears online ahead of publication.
The six-week open-label, parallel design study involved 89 diabetic patients with symptoms of gastroparesis who received either 10 or 20 mg metoclopramide nasal spray or 10 mg oral metoclopramide four times per day. Both doses of the nasal spray provided significantly better symptom control than the oral formulation.
Evoke President and CEO Dave Gonyer commented, “We believe the results from our Phase 2b clinical trial validate our novel intranasal delivery system of metoclopramide (EVK-001) which will be evaluated soon in our upcoming Phase 3 clinical trial. There haven’t been any new drugs for the management of symptoms associated with gastroparesis approved by the FDA since 1980, and there are very few drugs in clinical development for this debilitating diabetic complication.”
The company has previously said that the Phase 3 trial will begin in the first half of 2014.
Read the Evoke press release.
Read the article abstract.
