Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti™ NDA
April 02 2019 - 06:00AM
Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that it has 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.
“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.
About Gastroparesis
Gastroparesis is a debilitating, episodic
condition that disproportionately affects adult women and is
characterized by slow or delayed gastric emptying of the stomach’s
contents after meals, often resulting in flares of symptoms that
include nausea, vomiting, abdominal pain and bloating. Vomiting and
gastric emptying delays can cause unpredictable absorption of food
and oral medications, which complicate glucose control and can lead
to dehydration and malnutrition. These clinical manifestations of
gastroparesis also potentially render existing oral drug treatment
options ineffective. If approved, Gimoti would be the first
non-oral drug treatment for symptoms associated with acute and
recurrent diabetic gastroparesis in adult women and would represent
the first significant advancement in the treatment of gastroparesis
in 40 years.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company
focused primarily on the development of drugs to treat
Gastrointestinal (GI) disorders and diseases. The Company is
developing Gimoti, a nasal spray formulation of metoclopramide, for
the relief of symptoms associated with acute and recurrent diabetic
gastroparesis in adult women.
Diabetic gastroparesis is a GI disorder
affecting millions of patients worldwide, in which the stomach
takes too long to empty its contents resulting in serious digestive
system symptoms. The gastric delay caused by gastroparesis can
compromise absorption of orally administered medications.
Metoclopramide is currently available only in oral and injectable
formulations and is the only drug currently approved in the United
States to treat gastroparesis. Visit www.EvokePharma.com for more
information.
Safe Harbor Statement
Evoke cautions you that statements included in
this press release 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 cited by FDA in the CRL;
Evoke’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 Evoke that any of its plans will be achieved.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in Evoke’s
business, including, without limitation: Evoke 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 Evoke's conclusion of the root cause analysis or may
require Evoke to conduct additional studies; the inherent risks of
clinical development of Gimoti; Evoke’s dependence on third parties
for the manufacture of Gimoti and analysis of the PK data; Evoke is
entirely dependent on the success of Gimoti, and Evoke cannot be
certain that FDA will accept or approve an NDA resubmission for
Gimoti; Evoke 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; Evoke could face significant additional costs
due to litigation or other events; Evoke’s ability to maintain the
continued listing of its common stock on the Nasdaq Capital Market;
and other risks detailed in Evoke’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 Evoke undertakes no obligation to revise or update this press
release 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.
Investor Contact:The Ruth GroupTram BuiTel:
646-536-7035tbui@theruthgroup.com
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