According to Evoke Pharma, the company has reached an agreement with the FDA on design of a PK trial for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The company said that results of the PK trial are expected later this year, with an NDA submission expected no later than early 2018.
The company has previously announced that the FDA agreed in a December 2016 meeting to allow use of a comparative exposure PK trial to demonstrate bioequivalence of Gimoti to oral metoclopramide in a 505(b)(2) NDA and that the FDA has exempted Gimoti from human factors requirements.
Evoke Pharma President and CEO Dave Gonyer said, “We are pleased to have FDA’s input on the protocol for our comparative exposure PK trial, which, along with collecting CMC data associated with the trial, we believe are the last key items to be completed prior to submission of the NDA for Gimoti. In our communications and discussions with FDA, the agency provided advice on the proposed design of the study, which helps clear the path to move ahead with our timeline as scheduled. We remain confident in our ability to continue to execute on the milestones that we have outlined to bring Gimoti to commercialization.”
Read the Evoke Pharma press release.