Evoke Pharma Inc , a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases announced that it has entered into an agreement with Rho, Inc., a regulatory consulting and contract research organization (CRO).
Rho will assist Evoke with the preparation and submission of its planned 505(b)(2) New Drug Application (NDA) for Gimoti™, the Company’s patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
“We are actively laying the necessary groundwork to submit an NDA package for Gimoti to the U.S. Food and Drug Administration (FDA). We believe that it was imperative to select a CRO with relevant experience to optimize the chance of a successful submission leading to approval for Gimoti,” stated Dave Gonyer, R.Ph. President and CEO. “Rho has worked on other successful NDA submissions that have led to FDA approval of GI products, and we look forward to leveraging the experience of their dedicated team in the preparation of our application. In parallel, we remain on track to initiate and complete our PK study in the second half of this year with our NDA submission by 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 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.
About Rho, Inc.
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a broad range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies, as well as academic and government organizations.
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The Ruth Group
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com
