The FDA has approved Evoke Pharma’s Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, the company said. Evoke originally submitted an NDA for Gimoti in in June 2018 and acknowledged receipt of a complete response letter to that NDA in April 2019. The company resubmitted the NDA in December 2019.
In January 2020, Evoke announced that it had signed a 5-year commercialization and distribution agreement for Gimoti with Eversana after canceling a previous deal with Novus Growth Partners. The company now says that the approval triggers access to a $5 million line of credit from Eversana to cover manufacturing and other commercialization costs, and sales of Gimoti are expected to begin in the fourth quarter of 2020.
Evoke President and CEO Dave Gonyer commented, “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.”
Read the Evoke Pharma press release.
