Gimoti is Evoke's nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis. The
'We continue to build the Gimoti brand in preparation for potential product launch later this year. We remain excited for the possibility to provide a new product to those suffering from gastroparesis, especially those who experience delayed digestion of oral medications,' commented
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 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 in adult women and would represent the first significant advancement in the treatment of gastroparesis in 40 years.
About
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 nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
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 potential timing of FDA action on the NDA and potential approval and product launch for Gimoti; the timing and results of any decision regarding the Gimoti NDA from the FDA, including whether FDA will act by the PDUFA target goal date; Evoke's belief that Gimoti, if approved, can will provide an alternative to patients suffering from gastroparesis and whether Evoke's partnership with EVERSANA Life Sciences has laid the foundation for efficient and rapid commercialization of Gimoti, if approved. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke's business, including, without limitation: the scope of trademark protection may not provide the protections Evoke expects; the potential for the FDA to delay the PDUFA target goal date due to the
Contact:
Tram Bui
Tel: 646-536-7035
Email: tbui@theruthgroup.com
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