Evoke Pharma Receives Notice of Allowance From USPTO for a Patent Related to GIMOTI

Evoke Pharma, Inc. recently announced the USPTO issued a Notice of Allowance for US Application No. 16/469,092 for GIMOTI. When granted, the patent will cover methods for treating moderate-to-severe gastroparesis with metoclopramide with an intranasal route of administration. Once issued, the patent, titled Treatment of Moderate and Severe Gastroparesis, will expire in 2037. The patent will add to Evoke’s existing US FDA Orange Book-listed patents and other patents in the EU, Japan, and Mexico.

GIMOTI is the first and only FDA-approved novel nasal formulation of metoclopramide that is commercially available and specifically designed to deliver a non-oral dose of metoclopramide for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Non-oral delivery is an important treatment option as gastroparesis causes oral medications to be unpredictably absorbed and vulnerable to one of the key symptoms of the disease, vomiting.

The patent protects our Phase 3 clinical trial outcomes and data showing efficacy with nasal metoclopramide formulations for persons suffering from moderate-to-severe diabetic gastroparesis. The grant of this new patent further enhances Evoke’s growing position in this market and our continued efforts to ensure patients and doctors have access to GIMOTI in the US,” said Matt D’Onofrio, Chief Business Officer of Evoke Pharma. “Through market surveys and healthcare provider and patient anecdotes, we’ve learned that there is an imperative need for a nasal formulation of metoclopramide rather than the traditional standard of care. Therefore, we believe the transition from oral administration of metoclopramide to a nasal route is revolutionary for both patients and doctors, and we are thrilled to have IP protections in place to protect a novel product like GIMOTI.”

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 US to treat gastroparesis. For more information, visit www.EvokePharma.com.