Evoke Pharma has announced that the FDA will allow the company to move forward with an NDA for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis without a human factors validation study, exempting the product from requirements set out in the 2016 guidance titled “Applying Human Factors and Usability Engineering to Medical Devices.”
According to Evoke, the FDA accepted an HF assessment using a failure mode and effects risk analysis submitted by the company in lieu of the HF validation study.
Evoke President and CEO Dave Conyer commented, “We are very pleased with the continued FDA communication and their agreement that an HF validation study is not needed. This is another step closer to a potential NDA submission which our entire team remains focused to deliver this year. Given FDA agreement at a recent pre-NDA meeting to conduct a comparative exposure trial in healthy subjects, we are finalizing procedures to initiate that trial as soon as possible. We intend to pursue an NDA submission by the end of the year and plan to update our investors in the near term with more specific timelines on these efforts.”
Read the Evoke Pharma press release.
