Evoke Pharma completed Positive Type A Meeting with the FDA to confirms the acceptability of a proposed trial for Gimoti.
Evoke Pharma (NASDAQ:EVOK) completed Positive Type A Meeting with the FDA to confirms the acceptability of a proposed trial for Gimoti.
As quoted in the press release:
During a pre-NDA meeting announced in December 2016, FDA agreed with Evoke that a comparative exposure PK trial to demonstrate the bioequivalence of Gimoti in healthy volunteers could serve as the basis for a 505(b)(2) NDA submission for Gimoti. FDA recommended that Evoke submit the trial protocol for review prior to initiating the study, which Evoke provided in early March 2017. The Type A meeting was granted to allow comment and discussion with FDA regarding the structure, population and overall design of the PK trial. After discussing the protocol design with FDA, Evoke has agreed with their comments and plans to incorporate the Agency’s recommendations in the final protocol.
The pivotal comparative exposure PK trial will be conducted in healthy volunteers to demonstrate the bioequivalence of Gimoti to the reference listed drug, Reglan® Tablets. The Company is preparing to execute the trial and expects to have results in the second half of 2017. Additionally, agreement was received on items related to the CMC section of the NDA during the Type A meeting. The Company believes it will be able to submit the NDA for Gimoti by late 2017 or early 2018.
“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,” said Dave Gonyer, R.Ph., President and CEO of Evoke. “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.”
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. Gimoti is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through nasal administration. Visit www.EvokePharma.com for more information.