Evoke Pharma, Inc. has announced that it has completed the production of a commercial scale lot of EVK-001 as required by the U.S. Food and Drug Administration (FDA).
With the completion of this large scale production of EVK-001, the Company has demonstrated its ability to manufacture EVK-001, its patented intranasal formulation of metoclopramide, at commercial scale quantities in accordance with the FDA standards for chemistry, manufacturing, and controls (CMC).
In addition to data from this recent program, Evoke has a three-year registration stability data package from previous studies which have all met proposed specifications. These CMC datasets will be used as part of a New Drug Application (NDA) following data readout from Evoke's ongoing pivotal Phase 3 clinical trial for EVK-001.
Dave Gonyer, R.Ph., President and CEO, stated, "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."
Mr. Gonyer continued, "With 12 to 16 million patients in the U.S. who show symptoms of gastroparesis, there is a large market opportunity for a more effective treatment option than what is currently available. We believe EVK-001 can provide the relief that female patients need in a more predictable manner by avoiding the absorption problems typically experienced by people with this disease. We look forward to completing enrollment of our Phase 3 clinical trial in the second half of 2015 and providing data from this study."