Evoke Pharma has submitted a 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, the company said.
Earlier this year, Evoke announced that it had amended its deal with Mallinckrodt to defer milestone payments due on acceptance of review of the Gimoti NDA on final approval, with a single milestone now due a year after FDA approval. The company says that it expects acceptance of the NDA in early August. Patheon is set to manufacture the product if it is approved.
Evoke President and CEO Dave Gonyer commented, “Our NDA submission for Gimoti represents a significant step forward for Evoke and Gimoti, which has the potential to meaningfully improve the lives of patients who suffer from the devastating symptoms of gastroparesis. . . . Gimoti delivers metoclopramide, a well-characterized motility and antiemetic drug, as a nasal spray. We believe that Gimoti can make an important difference in the lives of these patients and we look forward to FDA approval.”
Read the Evoke Pharma press release.
