Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for 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.
“We are extremely pleased to have received FDA approval to commercially market Gimoti in the United States. This approval represents the first novel pharmaceutical treatment for gastroparesis in several decades. Many times, patients do not experience adequate relief of their gastroparesis symptoms from current treatments, representing a significant need for a new approach to therapy. We are excited to be able to offer health care providers and their patients a unique non-oral treatment option to relieve symptoms and help improve their quality of life,” said David Gonyer, R.Ph., President and CEO
“Patients with gastroparesis suffer from characteristic symptoms such as nausea, abdominal pain, bloating, early satiety as well as vomiting which can be severe and debilitating. These patients often have erratic absorption of orally administered drugs due to delayed gastric emptying,” stated Henry Parkman, MD, Stanley H. Lorber Research Endowment Fund and Chair, and Director, Gastroenterology Motility Laboratory, School of Medicine at Temple University. “Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy.”
“Together with our partner EVERSANA, we are now fully focused on executing our commercialization strategy for GIMOTI by leveraging EVERSANA’s integrated suite of capabilities and highly experienced sales and marketing team,” continued David Gonyer, R.Ph. “We anticipate initiating commercial sales in the fourth quarter of 2020.”
The FDA approval of Gimoti allows Evoke to access its existing $5 million line of credit from EVERSANA to support manufacturing and other aspects of GIMOTI’s commercialization. As of May 31, 2020, the Company’s cash and cash equivalents were approximately $4.7 million. Evoke believes, based on its current operating plan, that its cash and cash equivalents, together with the EVERSANA line of credit, will support the company’s operations into 2021, without consideration of potential GIMOTI revenue.
Gimoti is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Important Safety Information
WARNING: TARDIVE DYSKINESIA
Gimoti is not recommended for use in:
Gimoti is contraindicated:
Most common adverse reactions (≥5%) for Gimoti are: dysgeusia, headache, and fatigue.
These are not all of the possible side effects of Gimoti. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company developed 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. Visit www.EvokePharma.com for more information.