Evoke Pharma Inc., of Solana Beach, Calif., which has struggled in the past year through troughs in its stock price and doubts from the FDA in its quest for approval for Gimoti (metoclopramide), was vindicated today as the FDA approved the treatment for adults with acute and recurrent diabetic gastroparesis.

Company stock (NASDAQ:EVOK) closed 2.62% upward Friday afternoon at $2.35 per share. A year ago, it was a different story, as shares sold for 62 cents each on June 17, 2019. In November, the company was given a 180-day grace period to regain Nasdaq compliance with the minimum $1 bid price requirement.

Gimoti, a nasal spray formulation of metoclopramide designed to inhibit dopamine D2 and serotonin 5-HT3 receptors, was approved on its PDUFA date, June 19. The company noted that Gimoti is “the first and only nasally administered product” for the indication, as it is designed to bypass the disease gastrointestinal track and enter the bloodstream directly.

David Gonyer, Evoke’s president and CEO, said Friday afternoon that the treatment “represents the first novel pharmaceutical treatment for gastroparesis in several decades.”

The company expects to initiate commercial sales in the fourth quarter of 2020. In January, Eversana Life Science Services LLC, of Chesterfield, Mo., was named to commercialize Gimoti in the U.S. for diabetic gastroparesis. Eversana will fund and manage substantially all of the sales activities for Gimoti. Certain costs will be reimbursed by Evoke, and Eversana will earn a percentage of product profits in the mid to high teens when Gimoti net sales surpass certain administrative, manufacturing and commercialization costs. Evoke will record sales of the drug and retain more than 80% of profits for the product.

The FDA approval allows Evoke to access its existing $5 million line of credit from Eversana to support manufacturing and other aspects of commercialization.

The path to approval has been bumpy. On March 4, Evoke received a multidisciplinary review (DR) letter from the FDA, questioning if the review of Gimoti would be completed by its April 1 PDUFA date. The DR raised questions about Gimoti's efficacy, chemistry and production, according to Evoke. The first was about chemistry, with the FDA commenting on the combination product quality control and reproducibility specific to the commercially available sprayer device Gimoti uses. Clinically, the FDA commented on a lack of information to support sex-based efficacy differences. There was also concern about maximum concentration (Cmax) of the medicine not being within the parameters for bioequivalence for the ANDA.

Solana Beach, Calif.-based Evoke's April 2 response noted that the "clinical pharmacology issue was specific to a low Cmax in subjects representing less than 5 percent of the total administered Gimoti doses in the pivotal pharmacokinetic (PK) study. The agency stated the overall lower mean Cmax was driven by the data from these few subjects. Without the aberrant doses, the company's analysis shows the data met the bioequivalence criteria for both men and women. The agency recommended a root cause analysis to determine the origin of the PK variability and mitigation strategies to address the issue.

Then in early April 2019, Evoke received a complete response letter (CRL) as a follow-up to the DR. The CRL stated the FDA could not approve the NDA in its present form and provided recommendations for addressing two remaining approvability issues. No new clinical data were requested from the FDA and safety concerns were not raised, the company said.

Also in January, the FDA accepted resubmission of the 505(b)(2) NDA. In May, the FDA conditionally accepted the proprietary brand name, Gimoti.

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