Evoke Pharma (NASDAQ: EVOK) shares rallied as much as 11% this morning after the company provided details of its positive Type A meeting with the U.S. Food and Drug Administration (FDA). Evoke met with the FDA to finalize the design of the pivotal comparative exposure pharmacokinetic (PK) trial and to reach agreement on additional aspects of the Chemistry, Manufacturing & Controls (CMC) section of the New Drug Application (NDA) for Gimoti™ for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. 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 expects to have results in the second half of 2017 and 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,” president and CEO Dave Gonyer, R.Ph., stated in the news release.
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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. For more information, visit www.evokepharma.com.
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