In an update provided over the weekend, Evoke Pharma Inc. (NASDAQ: EVOK) said that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gimoti nasal spray for symptom relief in adults with acute and recurrent diabetic gastroparesis.
This approval of Gimoti gives Evoke Pharma access to its existing $5 million line of credit from Eversana to support manufacturing and other aspects of Gimoti’s commercialization.
Note that at the end of May, the company only had $4.7 million in cash and cash equivalents. Management has said that current cash and cash equivalents combined with this line of credit should be sufficient to support the company’s operations into 2021, without consideration of potential Gimoti revenue.
David Gonyer, R.Ph., president and CEO, noted, “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.” He added, “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.”
Diabetic gastroparesis is a gastrointestinal disorder affecting millions of patients worldwide. With this disorder, the stomach takes too long to empty its contents, resulting in serious gastrointestinal symptoms, as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications.
On Monday, Evoke Pharma stock traded up about 69% to $3.97, in a 52-week range of $0.50 to $5.00.
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