Evoke's Gimoti shows bioequivalence to Reglan in PK trial

Evoke Pharma Inc. (NASDAQ:EVOK) reported top-line data from a pharmacokinetic trial showing that 2 of 3 doses of Gimoti (EVK-001) achieved bioequivalence based on the area under the plasma concentration curve (AUC) within the range of 80-125% of Reglan metoclopramide tablets. Next quarter, Evoke plans to submit an NDA to FDA for 1 of the doses of Gimoti to treat symptoms associated with acute and recurrent diabetic gastroparesis.

The open-label, 4-way crossover trial enrolled 108 healthy volunteers to receive 1 Reglan dose and 3 different Gimoti doses in random sequence. The trial used a 90% confidence interval for its AUC comparison of each Gimoti dose to Reglan. Evoke said the maximum observed plasma concentration (Cmax) for Gimoti was “slightly lower than the bioequivalence range,” but that it had already discussed the likelihood of that result with FDA based on Gimoti’s route of administration and prior pharmacokinetic data. Gimoti is an intranasal formulation of metoclopramide, a dopamine D2 receptor antagonist (see BioCentury, Feb. 22)...