EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Other Events
Item 8.01Other Events.
On April 2, 2019, Evoke Pharma, Inc. (“Evoke” or the “Company”) announced that it had received a Complete Response Letter (CRL) from the U.S. 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.
The CRL, which cites fewer issues than the recent multidisciplinary review letter, states that 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.
The clinical pharmacology issue was specific to a low Cmax in subjects representing less than 5% 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. Additionally, FDA requested data from previously planned registration batches of commercial product to be manufactured by the Company. These data were requested to provide additional support for the proposed acceptance criteria for droplet size distribution after actuation of the sprayer device.
The Company believes that the issues raised by the CRL, which were related to the concerns over reproducible dose delivery, can be addressed, and expects to meet and work with FDA to gain a full understanding of the Agency’s requirements for approval.
Safe Harbor Statement
The Company cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding: the addressability of the approvability issues raised by FDA in the CRL; the Company’s plans to meet and work with FDA on the CRL deficiencies; and the potential for an NDA resubmission. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent inthe Company’s business, including, without limitation: the Company may be unable to timely and successfully address the deficiencies raised in the CRL, including as a result of adverse findings from a root cause analysis or data from newly manufactured product batches; FDA may not agree with the Company’s conclusion of the root cause analysis or may require the Company to conduct additional studies; the inherent risks of clinical development of Gimoti; The Company’s dependence on third parties for the manufacture of Gimoti and analysis of the PK data; the Company is entirely dependent on the success of Gimoti, and
the Company cannot be certain that FDA will accept or approve an NDA resubmission for Gimoti; the Company will require substantial additional funding to address the deficiencies raised in the CRL, and may be unable to raise capital or obtain funds when needed, including to fund ongoing operations; the Company could face significant additional costs due to additional litigation or other events; the Company’s ability to maintain the continued listing of its common stock on the Nasdaq Capital Market; and other risks detailed in the Company’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
About EVOKE PHARMA, INC. (NASDAQ:EVOK)
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. EVK-001 is a formulation of Metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The Company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging Phase IIb clinical trial. The Company has commenced a Phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females.
