Evoke Achieves Manufacturing Milestone

Evoke Pharma, Inc. has completed the production of a commercial scale lot of EVK-001 in accordance with FDA standards for chemistry, manufacturing, and controls (CMC), demonstrating its ability for large scale production of its intranasal formulation of metoclopramide.     

Along with previous studies, which have all met proposed specifications, these CMC datasets will be used as part of a NDA following data from Evoke’s Phase III trial for EVK-001 in treating symptoms related to diabetic gastroparesis in women.

Dave Gonyer, R.Ph., president and chief executive officer, said, “The ability to successfully manufacture EVK-001 at commercial scale volumes, along with our existing registration stability dataset that meets FDA requirements, is another important milestone for Evoke. This moves us one step closer to our ultimate goal of providing patients and their health care providers with an improved standard of care for treating symptoms related to diabetic gastroparesis in women. This is just one of the many steps we have accomplished and will continue to pursue, as we work toward FDA approval.”