Replies to post #1076 on Evoke Pharma Inc. (EVOK)

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GlobeNewswire•6 minutes ago
FDA Exempts Evoke from Requirement for Human Factor Validation Study
SOLANA BEACH, Calif., Feb. 15, 2017-- Evoke Pharma, Inc., a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, today announced that it has received a letter from FDA ...





FDA Exempts Evoke from Requirement for Human Factor Validation Study

GlobeNewswire•February 15, 2017Comment
SOLANA BEACH, Calif., Feb. 15, 2017 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, today announced that it has received a letter from FDA exempting its late stage product, Gimoti™ from a Human Factors (HF) Validation study requirement prior to submission of a New Drug Application (NDA).

In February 2016, FDA published new guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices”, which requires drug products classified as a drug/device combination, such as Gimoti, undergo evaluation that may require an HF Validation study as described in FDA’s Guidance.

To comply with this new Guidance, Evoke evaluated the need for an HF Validation study and submitted an HF assessment report to FDA for Gimoti using a Failure Mode and Effects Analysis risk analysis taking into account the intended uses, users, use environments, product-user interface, and associated medical factors. In their written response, FDA stated Evoke had adequately considered the risks associated with the proposed Gimoti nasal spray and determined that an HF Validation study is not needed at this time. The favorable FDA response helps reduce potential risks and saves additional resources in the development process including NDA preparation.

“We are very pleased with the continued FDA communication and their agreement that an HF Validation study is not needed. This is another step closer to a potential NDA submission which our entire team remains focused to deliver this year," commented Dave Gonyer R.Ph., President and CEO. Mr. Gonyer continued, “Given FDA agreement at a recent pre-NDA meeting to conduct a comparative exposure trial in healthy subjects, we are finalizing procedures to initiate that trial as soon as possible. We intend to pursue an NDA submission by the end of the year and plan to update our investors in the near term with more specific timelines on these efforts.”

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.