Evoke Pharma, Inc.: Gimoti

Please refer to your New Drug Application (NDA) dated May 30, 2018, received June 1, 2018, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), for Gimoti (metoclopramide nasal spray).

Your pharmacokinetic (PK) bridge between the Gimoti 15 mg dose and the Reglan tablet 10 mg is insufficient to justify the reliance on the findings of safety and efficacy for Reglan to assure comparable safety and efficacy between Gimoti and Reglan.

Several subjects demonstrated low Cmax (<5 ng/ml) for metoclopramide with one or more Gimoti administrations.

To address the clinical pharmacology deficiency, we recommend that you investigate the root cause(s) for the variability in PK for Gimoti, including the issue of inconsistent and incomplete delivery.

Upon resubmission, all proposed tests and acceptance criteria including the droplet sizes and other essential performance characteristics for the commercial product specification should be supported by three batches of drug product using the selected commercial formulation (including strength of the product) and the commercial device.

The following comments are not approvability issues but should be addressed in the complete response submission.

Upon resubmission the proposed shelf life should be supported by three batches of the drug product using the selected commercial formulation (including strength of the product) and the proposed commercial device.