Evoke Pharma announced that it has entered into an agreement with Rho, a regulatory consulting and contract research organization (CRO). Rho will assist Evoke with the preparation and submission of its planned 505(b)(2) New Drug Application (NDA) for Gimoti, the company's patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
"We are actively laying the necessary groundwork to submit an NDA package for Gimoti to the U.S. Food and Drug Administration (FDA). We believe that it was imperative to select a CRO with relevant experience to optimize the chance of a successful submission leading to approval for Gimoti," Dave Gonyer, R.Ph. President and CEO said. "Rho has worked on other successful NDA submissions that have led to FDA approval of GI products, and we look forward to leveraging the experience of their dedicated team in the preparation of our application. In parallel, we remain on track to initiate and complete our PK study in the second half of this year with our NDA submission by late 2017 or early 2018."