Evoke Pharma Inc (NASDAQ: EVOK) took a thumping at Monday’s opening bell , after the company disclosed 'positive' topline results from comparative exposure pharmacokinetic study for Gimoti.
The company, based out of Solana Beach, Calif., said the trial was designed to demonstrate that a proposed dose of Gimoti, the Company’s patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, has similar systemic exposure to that of the referenced listed drug (RLD), Reglan Tablets.
Based on the results, the Company will submit a 505(b)(2) New Drug Application (NDA) with a selected Gimoti dose to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018.
Said CEO Dave Gonyer, “we are very pleased this study has met our objective of demonstrating bioequivalence on the measure of AUC to identify a Gimoti dose.
"In the first quarter of 2018, we will submit the NDA with these PK data, as well as safety and efficacy data from five prior Evoke clinical studies in healthy volunteers and patients with diabetic gastroparesis. We believe Gimoti has the potential to become the new standard of care for patients suffering from this debilitating disease and we look forward to providing further updates regarding the NDA as we move quickly toward submission."
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus.
Evoke stock began the day and the week down 49 cents, or 14.2%, to $2.96.
