U.S. Food and Drug Administration's (FDA) Draft Guidance is Consistent With Evoke's Current Phase 3 Study Design and Endpoint for EVK-001

Evoke Pharma, Inc.

, a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that its Phase 3 clinical trial design for EVK-001 (metoclopramide nasal spray) is consistent with the FDA's recommendations in the recently released draft guidance entitled Gastroparesis: Clinical Evaluation of Drugs for Treatment – Guidance for Industry (Draft Guidance). The new Draft Guidance contains the FDA's current thinking on trial design and study endpoints for drug development in the treatment of gastroparesis. "We are pleased to see the recommendations contained in the FDA's Draft Guidance on gastroparesis are consistent with the feedback we received from the FDA for our Phase 3 study of EVK-001, which gives us further confidence in the design of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," said Dave Gonyer, R.Ph., President and CEO. "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concerns, we believe there is less regulatory risk with our development program for EVK-001 as it relates to this Draft Guidance." "The recommendations in the Draft Guidance are in line with the feedback we received from the FDA during our end of phase 2 meetings regarding the design and plans for the EVK-001 Phase 3 study, which led to our selection of the primary endpoint in the study, which consists of a patient-reported outcome (PRO) instrument for gastroparesis symptoms," said Marilyn R. Carlson, D.M.D., M.D., RAC, Chief Medical Officer. "This Draft Guidance provides recommendations for the design and endpoints used in gastroparesis clinical trials and outlines the FDA's expectation that all sponsors will develop a well-defined and reliable PRO instrument consistent with a drug's mechanism of action for use as the primary efficacy assessment tool in their clinical trials." Dr. Carlson continued, "We are further encouraged by specific statements made within the Draft Guidance that acknowledge patients with diabetic gastroparesis may have unpredictable gastric emptying and altered absorption of orally-administered hypoglycemic drugs. Importantly, we believe the FDA's statements highlight the need for non-oral drugs like EVK-001 to treat the symptoms of gastroparesis. We believe that our intranasal formulation of metoclopramide is the only non-oral and non-injectable product in development and, if approved, may have the distinct advantage of being on the market for several years as the only new treatment approved to address this debilitating disease in these patients with erratic gastric emptying."