FDA Accepts Evoke Pharma’s NDA Resubmission for Gimoti

PDUFA Target Goal Date is June 19, 2020

SOLANA BEACH, Calif., Jan. 21, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on the development of drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s resubmission of its 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.

A six-month period of review from the FDA’s date of receipt has been assigned for the resubmitted NDA and the application has been assigned a new Prescription Drug User Fee Act (PDUFA) target goal date of June 19, 2020.

“We are pleased that FDA has accepted our NDA resubmission and look forward to working with the Agency throughout the review process toward a potential approval,” commented Dave Gonyer, President and CEO. “We will now turn our focus to ensuring commercial readiness, as we believe physicians and patients are in urgent need of a new treatment option for the management of diabetic gastroparesis. We remain confident that Gimoti can help fill this unmet medical need and improve the quality of life for patients suffering from this disease.”

About Gastroparesis

Gastroparesis is a debilitating, episodic condition that disproportionately affects adult women and is characterized by slow or delayed gastric emptying of the stomach’s contents after meals, often resulting in flares of symptoms that include nausea, vomiting, abdominal pain and bloating. Vomiting and gastric emptying delays can cause unpredictable absorption of food and oral medications, which complicate glucose control and can lead to dehydration and malnutrition. These clinical manifestations of gastroparesis have the potential to render existing oral drug treatment options ineffective. If approved, Gimoti would be the first non-oral outpatient drug treatment for symptoms associated with acute and recurrent diabetic gastroparesis in adult women and would represent the first significant advancement in the treatment of gastroparesis in 40 years.