FDA wants additional information on Evoke's Gimoti

Evoke said FDA issued a complete response letter to its NDA for Gimoti to treat acute and recurrent diabetic gastroparesis in women.

Evoke Pharma Inc. (NASDAQ:EVOK) said the agency raised clinical pharmacology and product quality issues and recommended mitigation strategies to address the low Cmax observed in less than 5% of patients administered Gimoti (EVK-001) in a pivotal PK study and a root cause analysis to determine the origin of the variability. The company reported top-line data from the trial in 2017 (see "Evoke's Gimoti Shows Bioequivalence to Reglan in PK Trial")...