Evoke Pharma, Inc. said this week that its Phase 3 clinical trial design for EVK-001 is consistent with the U.S. Food and Drug Administration's (FDA) recommendations in its recently released draft guidances.
The new guidelines, "Gastroparesis: Clinical Evaluation of Drugs for Treatment – Guidance for Industry (Draft Guidance)," includes the FDA's current thinking on trial design and study endpoints for drug development in the treatment of gastroparesis.
Evoke is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus.
"We are pleased to see the recommendations contained in the FDA's Draft Guidance on gastroparesis are consistent with the feedback we received from the FDA for our Phase 3 study of EVK-001, which gives us further confidence in the design of our ongoing study," Dave Gonyer, president and CEO of Evoke Phama, said. "Our patented nasal delivery of metoclopramide for the treatment of symptoms associated with diabetic gastroparesis in women is one of only a few products in development for this disease. With a Phase 3 clinical trial design and endpoint that are consistent with the specific recommendations for protocol design, endpoint analysis and disease-specific concerns, we believe there is less regulatory risk with our development program for EVK-001 as it relates to this Draft Guidance."
Evoke is a specialty pharmaceutical company focused mainly on the development of drugs to treat GI disorders and diseases.