Evoke Pharma - United States Patent and Trademark Office Grants another Formulation Patent Covering GIMOTI
November 15, 2023 at 09:04 am EST
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SOLANA BEACH - Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI nasal spray, announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,813,231 titled Nasal Formulations of Metoclopramide , pertaining to the Company s commercially available and FDA-approved nasal formulation of metoclopramide, GIMOTI.
This new patent, issued on November 14, 2023, provides Evoke with additional intellectual property protections with claims to metoclopramide being delivered intranasally, amongst others. Evoke continues to see significant commercial value, particularly with the rising popularity of GLP-1 agonist medications for diabetes which are potentially unmasking gastroparesis (stomach paralysis) in larger groups of patients. GIMOTI is the only outpatient, non-oral drug labeled for the treatment of acute and recurrent diabetic gastroparesis. The ability to take the medication non-orally is important as gastroparesis causes tablets to be unpredictably absorbed. Pills may linger in the stomach instead of being passed into the intestines for absorption or not absorbed at all due to one of the key symptoms of the disease, vomiting.
We continue to witness the significance of GIMOTI in the marketplace through various validation points, including patient and market data, growing revenues, and a robust stream of patent protections. We are thrilled to continue providing patients a life-changing experience with diabetic gastroparesis treatment and bolster the already promising commercial opportunity for GIMOTI, commented Matt D Onofrio, President and COO of Evoke Pharma.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. 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 GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.
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 anticipated scope and term of any patent protection for Gimoti and the expected inclusion of any new patent in the FDA s Orange Book. 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: Evoke s ability to obtain, maintain and successfully enforce intellectual property protection for Gimoti; Evoke s and EVERSANA s ability to successfully drive market demand for Gimoti; Evoke s ability to obtain additional financing as needed to support its operations; the COVID-19 pandemic may continue to disrupt Evoke s and EVERSANA s business operations impairing the ability to commercialize Gimoti and Evoke s ability to generate any product revenue; Evoke s dependence on third parties for the manufacture of Gimoti; Evoke is entirely dependent on the success of Gimoti; inadequate efficacy or unexpected adverse side effects relating to Gimoti that could result in recalls or product liability claims and other risks and uncertainties detailed in Evoke s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development and commercialization of drugs to treat gastrointestinal (GI) disorders and diseases. The Company operates through the development and commercialization of pharmaceutical products. It is developing its product, Gimoti (metoclopramide) nasal spray, the first and only nasally administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. It developed Gimoti, a dopamine antagonist / mixed 5-HT3 antagonist / 5-HT4 agonist with pro-motility and anti-emetic effects, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. Gimoti is a novel formulation of metoclopramide offering systemic delivery by nasal spray administration. It has developed the nasal formulation of metoclopramide to provide its targeted patient population with acute or recurrent symptoms of diabetic gastroparesis.
EVOKE PHARMA, INC. 
