Evoke Pharma says that a comparative exposure PK study has shown that 2 out of 3 doses of its Gimoti metoclopramide nasal spray demonstrated bioequivalence to oral metoclopramide and, based on those results, the company plans to submit a 505(b)(2) NDA for Gimoti early in 2018. Evoke is developing Gimoti for the treatment of diabetic gastroparesis.
In December 2016, the company said that the FDA would allow it to move forward with the 505(b)(2) NDA for Gimoti despite the fact that a Phase 3 study had failed to meet its primary endpoint and that the agency would require only the bioequivalence study comparing the nasal spray to oral metoclopramide.
Evoke Pharma CEO Dave Gonyer said, “We are very pleased this study has met our objective of demonstrating bioequivalence on the measure of AUC to identify a Gimoti dose. In the first quarter of 2018, we will submit the NDA with these PK data, as well as safety and efficacy data from five prior Evoke clinical studies in healthy volunteers and patients with diabetic gastroparesis. We believe Gimoti has the potential to become the new standard of care for patients suffering from this debilitating disease and we look forward to providing further updates regarding the NDA as we move quickly toward submission.”
Read the Evoke Pharma press release.
