Evoke Pharma Receives Preliminary FDA Communication on Gimoti™ NDA

Evoke Pharma (NASDAQ:EVOK) has announced that it has received a multi-disciplinary review (DR) letter from the US Food and Drug Administration in connection a New Drug Application (NDA) for Gimoti 505(b)(2).

As quoted in the press release:

A DR letter is used by the FDA to convey preliminary thoughts on deficiencies identified during the initial stage of NDA review.

The letter described concerns in three sections of the NDA: Chemistry (combination product quality control and reproducibility specific to the commercially available sprayer device used with Gimoti); Clinical (lack of adequate information to support sex-based efficacy differences); and Clinical Pharmacology (maximum concentration (C_max) not within the parameters for bioequivalence for abbreviated NDAs). Although a DR letter reflects preliminary comments that are subject to change and does not reflect a final FDA decision on the NDA, approval of Gimoti by the PDUFA date of April 1, 2019 is uncertain given the letter.

The Company plans to respond to the deficiencies raised in the DR letter to allow time for potential FDA review prior to the PDUFA date.

“We were disappointed by this FDA notification and are in the process of evaluating and addressing FDA’s comments. We remain focused on seeking approval for Gimoti to provide patients with an effective treatment that bypasses the stomach where oral medications are known to be erratically absorbed,” said Dave Gonyer, CEO. “Predictably delivered therapeutic options for patients that suffer from gastroparesis remains of high interest to the Company and an important need for physicians and patients that suffer from gastroparesis.”

Click here to read the full press release.