The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Evoke Pharma regarding the New Drug Application (NDA) for Gimoti (metoclopramide nasal spray),  an investigational treatment for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.

In the CRL, the FDA stated that the NDA could not be approved in its present form based on issues related to pharmacology and product/device quality. Specifically, an issue related to pharmacokinetic variability was noted, with a low Cmax identified in some patients. In addition, data supporting droplet size distribution following actuation of the device was requested by the Agency.

“We believe that the issues cited in the CRL, which were related to concerns over reproducible dose delivery, can be addressed. We look forward to meeting with FDA to gain a full understanding of the Agency’s requirements for approval and remain committed to bringing our novel nasal formulation of metoclopramide to patients,” said Dave Gonyer, President and CEO.

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If approved, Gimoti would be the first non-oral pharmacotherapy for gastroparesis approved in 40 years; metoclopramide is currently available in oral and injectable formulations.

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