Evoke Pharma, Inc. , a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases announced that the Company has reached an agreement to work in partnership with Spaulding Clinical Research for its planned comparative exposure pharmacokinetic (PK) trial for its lead product candidate, Gimoti™, a patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
The pivotal PK trial conducted in healthy volunteers is designed to establish bioequivalence with the listed drug, Reglan® Tablets, and may serve as a basis for the 505(b)(2) new drug application (NDA) planned for submission to the FDA.
This PK trial follows recent communications with FDA regarding the final clinical development steps for the NDA submission. The Company held a face-to-face pre-NDA meeting with FDA in December 2016 to propose and discuss this PK trial and recently confirmed the final protocol design during a Type A Meeting with FDA last month. The Company engaged Spaulding to execute this trial and is now in the latter planning stages to initiate the trial.
“We are very pleased to continue our relationship with Spaulding Clinical for our PK trial for Gimoti and remain on schedule to initiate the trial in the second half of the year. We believe a successful PK trial will conclude our clinical development work for Gimoti and may provide the final data needed to complete the 505(b)(2) NDA,” said Marilyn R. Carlson, DMD, MD, RAC, Chief Medical Officer of Evoke. “Previously, the Spaulding team successfully initiated and completed our Gimoti thorough ECG trial in 2014. We look forward to completing the PK trial in the second half of 2017 with the NDA submission for Gimoti to follow in late 2017 or early 2018.”
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.
Spaulding Clinical Research, LLC is a global clinical research organization providing a range of Phase 1 — 4 drug development services to the biotechnology and pharmaceutical industries. Spaulding Clinical Research operates a 200-bed Clinical Pharmacology Unit, Cardiac Core Laboratory and provides full Biometrics/Scientific Affairs services. The company was founded in 2007 and is based in West Bend, Wisconsin.
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