Evoke Pharma Requests Type A FDA Meeting to Plan for Resubmission of Gimoti™ NDA
The purpose of the meeting is to discuss and gain clarity on the approvability issues relating to clinical pharmacology and product quality/device quality described in the CRL. During the meeting, Evoke plans to discuss the Company’s strategy to address these issues as well as any other matters pertaining to the steps required for the resubmission of the Gimoti NDA. No safety concerns were raised and no additional clinical data were requested in the CRL.
“We have been working diligently to prepare the meeting package required at the time a type A meeting request is submitted to
The type A meeting, if granted, is expected to occur within thirty days of FDA’s receipt of the meeting request and meeting package. Evoke will provide an update on the timing of resubmission of the NDA for Gimoti after receipt of the FDA’s final meeting minutes, which typically become available within thirty days after the type A meeting.
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 also potentially render existing oral drug treatment options ineffective. If approved, Gimoti would be the first non-oral drug treatment for symptoms associated with acute and recurrent diabetic gastroparesis 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, an investigational nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis.
Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. 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
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: the addressability of the approvability issues cited by
Source: Evoke Pharma, Inc.