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Evoke Pharma (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company’s 505(b)(2) New Drug Application (NDA) for Gimoti™, the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis, has been accepted for review by the U.S. Food …
Evoke Pharma (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company’s 505(b)(2) New Drug Application (NDA) for Gimoti™, the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis, has been accepted for review by the U.S. Food and Drug Administration (FDA).
As quoted in the press release:
In its Filing Communication/Day-74 letter, FDA stated that the NDA received on June 1, 2018, is sufficiently complete to permit a substantive review and set a target goal date under the Prescription Drug User Fee Act (PDUFA) of April 1, 2019. If approved, Gimoti will be the first new non-oral drug treatment option for diabetic gastroparesis in four decades.
“We are pleased with FDA’s acceptance of our NDA for filing, which reaffirms our commitment to bringing this novel non-oral drug product to adult women who suffer from diabetic gastroparesis. We believe that Gimoti holds the potential to significantly improve the quality of life for these patients, particularly those who fail to achieve adequate relief from current oral therapy, and often face debilitating symptom flares of nausea, vomiting and abdominal pain,” commented Dave Gonyer, President and CEO.
