The FDA issued a complete response letter to Evoke Pharma for its Gimoti (metoclopramide) nasal spray for treatment of diabetic gastroparesis, a condition that delays emptying of the stomach.
The agency flagged a low Cmax—the peak serum concentration a drug attains in a test area of the body after the first administration—in subjects representing less than five percent of the total administered Gimoti doses in the pivotal pharmacokinetic study, the company said.
“The agency stated the overall lower mean Cmax was driven by the data from these few subjects,” Evoke Pharma said. “Without the aberrant doses, the company’s analysis shows the data met the bioequivalence criteria for both men and women.”
The agency suggested that the company perform a root cause analysis to determine where the pharmacokinetic variability came from and recommended mitigation strategies.