FDA approves Gimoti for diabetic gastroparesis
Evoke Pharma announced in a press release that the FDA has approved the new drug application for Gimoti nasal spray to relieve symptoms in adults with acute and recurrent diabetic gastroparesis.
“We are extremely pleased to have received FDA approval to commercially market Gimoti [metoclopramide, Evoke Pharma] in the United States,” David Gonyer, R.Ph, president and CEO, said in the release. “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 healthcare providers and their patients a unique non-oral treatment option to relieve symptoms and help improve their quality of life.”
According to the release, the FDA approval will allow Evoke to access its existing $5 million line of credit from Eversana to support manufacturing and other aspects of metoclopramide commercialization. Evoke anticipates its line of credit combined with approximately $4.7 million in cash and cash equivalents will support Evoke’s operations into 2021, not including the potential metoclopramide revenue.
“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,” Gonyer said. “We anticipate initiating commercial sales in the fourth quarter of 2020.”