NetworkNewsBreaks – Evoke Pharma (NASDAQ: EVOK) Moves Forward with Comparative Exposure PK Trial for Gimoti NDA Following Type A Meeting with FDA

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.

To view the full press release, visit: http://nnw.fm/4eWb2

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.

About NetworkNewsBreak

NetworkNewsBreak (NNB) provides a rapid summary of corporate news that caught the attention of NetworkNewsWire (NNW). NNB keeps you up-to-date on active US Public Companies complementary to NNW’s broader scope as a provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s