FDA Accepts Evoke Pharma’s NDA Resubmission for Gimoti™
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
“We are pleased that
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.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The Company is developing Gimoti, a nasal spray formulation of metoclopramide, for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
Diabetic gastroparesis affects millions of patients worldwide and may result in serious digestive system symptoms, loss of glucose control, and systemic complications, such as dehydration and malnutrition. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Metoclopramide is currently available only in oral and injectable formulations and is the only drug currently approved in
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Source: Evoke Pharma, Inc.