Evoke Pharma Receives Notice of Allowance from USPTO for First & Only FDA-Approved Nasal Formulation of Metoclopramide Commercially Available in the US

Evoke Pharma, Inc. recently announced it has been granted a Notice of Allowance from the US Patent and Trademark Office (USPTO) for patent application No. 17/366,829 pertaining to GIMOTI, the first and only FDA-approved nasal formulation of metoclopramide commercially available in the US. When issued, the patent will cover the intranasal pharmaceutical composition of GIMOTI.

Upon issuance, the patent titled Nasal Formulations of Metoclopramide will be set to expire in 2029. Based on market, healthcare provider (HCP), and patient surveys, GIMOTI has demonstrated a meaningful reduction in utilization of healthcare resources and presents a novel solution to diabetic gastroparesis treatment by delivering a non-oral dose of metoclopramide to relieve symptoms in adults associated with this disease. GIMOTI has been commercially available in the US since 2020 and is currently prescribed by over a thousand HCPs nationwide.

“This soon-to-issued patent further establishes our commercial and intellectual property footprint within the GI therapeutic space. We continue to hear stories of lives being changed with GIMOTI and we believe our product can become the first-line treatment for those who suffer from the debilitating symptoms of diabetic gastroparesis. This disease continues to grow due to the increase in prevalence of diabetes and we are receiving significant market feedback regarding the implications of the new GLP-1 treatments which may uncover delayed gastric emptying. Diabetes and gastroparesis (delayed gastric emptying) remains our focus and GIMOTI is the only non-oral outpatient treatment indicated to address the nausea, vomiting, abdominal pain and other symptoms brought on by this difficult disease,” said David Gonyer, RPh, Chief Executive Officer of Evoke Pharma.

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. For more information, visit www.EvokePharma.com.