Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the European Patent Office has issued a Decision to Grant European Union (EU) patent no. 2747561 for Gimoti™, covering formulations of metoclopramide for intranasal delivery for the treatment of symptoms associated with diabetic gastroparesis specifically for women. The notice confirms that the patent grant applies to 38 covered member states and will be published on May 9, 2018 with patent expiry extended to 2032.
“This patent represents the first female specific intellectual property approved for Gimoti and highlights the significant work we’ve accomplished in developing this novel new treatment for gastroparesis,” commented Dave Gonyer, President and CEO. “Based on our research findings, we have also filed other formulation, efficacy, pharmacokinetic, and dosing patents directed toward the specific profile in women in order to further solidify our intellectual property position.”
Gastroparesis, which often compromises the ability for oral medications to pass through the stomach to allow predictable absorption, remains a significant burden on patients, 80% of whom are women. Through Evoke’s extensive gastroparesis research, the Company has developed Gimoti, its nasal formulation of metoclopramide, to deliver an effective medication while bypassing the dysfunctional stomach. This non-oral treatment is an important improvement in relieving symptoms of this debilitating disease, where approximately 4 million prescriptions of oral metoclopramide are written each year in the United States.
The company is currently preparing to submit its 505(b)(2) New Drug Application (NDA) for Gimoti to the U.S. Food and Drug Administration (FDA) within the second quarter 2018.
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 is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. Gimoti is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through nasal administration. Visit www.EvokePharma.com for more information.