Having outlined a list of lingering concerns with Evoke Pharma’s marketing application for its sole drug last month, the FDA solidified its dissent with an outright rejection, the company revealed on Tuesday.
The treatment, Gimoti, is an intranasal spray formulation of the FDA-approved metoclopramide designed to surmount the limitations of oral administration in patients experiencing diabetic gastroparesis — characterized by slow or delayed gastric emptying — that can cause nausea, vomiting, and obstruction in the stomach, thwarting drug absorption. The drug also specifically targets women, who are disproportionately affected by the condition.
Evoke has done its utmost to drag the drug to the finish line, despite its chequered past. It failed a Phase III study three years ago, eviscerating the stock. Financially strapped, Evoke ran a series of post-hoc analyses to conclude that Gimoti was effective among patients with moderate-to-severe symptoms, including nausea and upper abdominal pain, instead of running another late-stage trial. The firm also unveiled fresh pharmacokinetic data to demonstrate “statistically significant differences in exposure between men and women given the same metoclopramide dose.”
Although the FDA agreed to review the drug on these data and analyses, last month the agency appeared apprehensive about Gimoti in the initial stage of its review, flagging concerns about chemistry, clinical and pharmacology information included in the drug’s application.
On Tuesday, Evoke $EVOK said the complete response letter (CRL) — focused on concerns related to clinical pharmacology and device quality — cited “fewer issues” than the March communication, and that the agency did not request any new clinical data or raise safety concerns. The company’s shares tumbled nearly 35% to $1.11 in premarket trading.
“We believe that the issues cited in the CRL, which were related to concerns over reproducible dose delivery, can be addressed,” said Evoke chief Dave Gonyer in a statement, adding that the company planned to meet with the agency to discuss the next steps for the program.
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