Evoke Pharma announced Tuesday that the FDA issued a complete response letter regarding a filing under the 505(b)(2) pathway seeking approval of Gimoti, a nasal formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. The company, whose shares fell nearly 40 percent on the news, noted that the issues raised in the letter are related to clinical pharmacology and product quality/device quality.
Last month, the FDA issued Evoke a multi-disciplinary review letter regarding the application, raising concerns over three sections of the submission. At the time, the company said that the problems related to quality control and reproducibility specific to the commercially available sprayer device used with Gimoti, lack of adequate information to support sex-based efficacy differences and the maximum concentration of the drug not being within the parameters for bioequivalence for abbreviated applications.
Evoke indicated Tuesday that the complete response letter cites fewer issues than in the FDA's prior communication, namely those related to clinical pharmacology and product quality/device quality. CEO Dave Gonyer said "we believe that the issues…which were related to concerns over reproducible dose delivery, can be addressed."
In 2016, Evoke reported top-line results from a Phase III trial, showing that Gimoti did not achieve its primary endpoint of symptom improvement at week four compared to placebo. The company subsequently said that patients with moderate-to-severe symptoms responded significantly better when treated with the drug than those on placebo at multiple time points in the study. Evoke submitted the filing to the FDA last year, seeking clearance of Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
