New treatment for gastroparesis preparing for FDA submission

Evoke Pharma, Inc. announced positive topline results from the Company's comparative exposure pharmacokinetic (PK) study. 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 FDA in the first quarter of 2018.

The PK study was an open label, 4-way crossover and enrolled 108 male and female healthy volunteers who were each to receive one Reglan Tablet dose and three different doses of Gimoti in a random sequence. Following discussions at pre-NDA meetings with the FDA, Evoke planned to select a Gimoti dose based on criteria that includes a 90% confidence interval for the ratio of area under the plasma concentration curve (AUC) falling within the bioequivalence range of 80-125% of the RLD. Two of the three doses tested met the selection criteria. The maximum observed plasma concentration (Cmax) for Gimoti was slightly lower than the bioequivalence range, which had been previously discussed with FDA as a likely outcome given the different route of administration and prior Gimoti PK study results. Additionally, data showed the AUC and Cmax increased in a dose related manner across all three strengths tested. Relative to safety, all Gimoti doses were well?tolerated with no clinically significant adverse events reported following any of the doses.This study has met its objective of demonstrating bioequivalence on the measure of AUC to identify a Gimoti dose.

Comment: Gimoti has been in development for over a decade to provide a non-oral, outpatient alternative to treat the symptoms of gastroparesis in patients. Non-oral treatment is optimal as gastroparesis, also known as gastric stasis, results in erratic absorption of oral medications. Metoclopramide, the active ingredient in Gimoti, has been approved as a tablet and an injection to treat gastroparesis in the US since 1980. Approximately 4 million prescriptions of oral metoclopramide are written per year in the US..