Evoke Pharma: FDA Accepts EVK-001 Pediatric Study Plan - Quick Facts

(RTTNews) - Evoke Pharma, Inc. (EVOK) announced the FDA has accepted the company's proposed pediatric study plan for EVK-001, which included a request for a full waiver of the requirement to conduct pediatric studies on the basis that diabetic gastroparesis is an adult disease. The company expects the pediatric study plan will be included in the anticipated New Drug Application filing with the FDA.

Gonyer, CEO, said: "We believe that this agreement, along with the recent FDA guidance document that assists companies in the clinical development of drugs for the treatment of gastroparesis, specifically trial design and clinical endpoint evaluation, are consistent with the advice given by the FDA on the design of our current Phase 3 clinical development program."