FDA delays Gimoti approval, issuing CRL

USA-based Evoke Pharma (Nasdaq: EVOK) says it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its 505(b)(2) New Drug Application (NDA) for Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis.

Gimoti, a patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women, is Evoke’s only product. News of the delay sent the firm’s shares plunging more than 47% to $0.90 by close of trading on Tuesday.

The CRL, which cites fewer issues than the recent multidisciplinary review letter, states that the FDA has determined it cannot approve the NDA in its present form and provides recommendations to address the two remaining approvability issues in an NDA resubmission. The issues are related to clinical pharmacology and product quality/device quality. The agency did not request any new clinical data and did not raise any safety concerns.