Positive Type A Meeting with FDA Confirms Acceptability of Evoke Pharma’s Proposed Comparative Exposure PK Trial for Gimoti...
April 04 2017 - 8:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that the Company recently completed a positive Type
A meeting with the U.S. Food and Drug Administration (FDA) to
finalize the design of the pivotal comparative exposure
pharmacokinetic (PK) trial and to reach agreement on additional
aspects of the Chemistry, Manufacturing & Controls (CMC)
section of the New Drug Application (NDA) for Gimoti™, the
Company’s patented nasal delivery formulation of metoclopramide for
the relief of symptoms associated with acute and recurrent diabetic
gastroparesis in adult women.
During a pre-NDA meeting announced in December
2016, FDA agreed with Evoke that a comparative exposure PK trial to
demonstrate the bioequivalence of Gimoti in healthy volunteers
could serve as the basis for a 505(b)(2) NDA submission for Gimoti.
FDA recommended that Evoke submit the trial protocol for review
prior to initiating the study, which Evoke provided in early March
2017. The Type A meeting was granted to allow comment and
discussion with FDA regarding the structure, population and overall
design of the PK trial. After discussing the protocol design with
FDA, Evoke has agreed with their comments and plans to incorporate
the Agency’s recommendations in the final protocol.
The pivotal comparative exposure PK trial will
be conducted in healthy volunteers to demonstrate the
bioequivalence of Gimoti to the reference listed drug, Reglan®
Tablets. The Company is preparing to execute the trial and expects
to have results in the second half of 2017. Additionally, agreement
was received on items related to the CMC section of the NDA during
the Type A meeting. The Company believes it will be able to
submit the NDA for Gimoti by late 2017 or early 2018.
“We are pleased to have FDA’s input on the
protocol for our comparative exposure PK trial, which, along with
collecting CMC data associated with the trial, we believe are the
last key items to be completed prior to submission of the NDA for
Gimoti,” said Dave Gonyer, R.Ph., President and CEO of Evoke. “In
our communications and discussions with FDA, the Agency provided
advice on the proposed design of the study, which helps clear the
path to move ahead with our timeline as scheduled. We remain
confident in our ability to continue to execute on the milestones
that we have outlined to bring Gimoti to commercialization.”
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company
focused primarily on the development of drugs to treat GI disorders
and diseases. The Company is developing Gimoti, a metoclopramide
nasal spray for the relief of symptoms associated with acute and
recurrent gastroparesis in women with diabetes mellitus. Diabetic
gastroparesis is a GI disorder afflicting millions of sufferers
worldwide, in which the stomach takes too long to empty its
contents resulting in serious digestive system symptoms.
Metoclopramide is the only product currently approved in the United
States to treat gastroparesis, and is currently available only in
oral and intravenous forms. Gimoti is a novel formulation of this
drug, designed to provide systemic delivery of metoclopramide
through nasal administration. 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: Evoke
plans to incorporate the Agency’s recommendations in the final
trial protocol; the trial being the last outstanding item needed
prior to submission of the NDA for Gimoti; and Evoke's plans to
conduct and complete the PK trial and submit the NDA and the timing
thereof. 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: risks associated
with successfully commencing and receiving favorable results from
the planned trial; later developments with FDA that may be
inconsistent with the already completed pre-new drug application
(NDA) and Type A meetings; the inherent risks of clinical
development of Gimoti; Evoke is entirely dependent on the success
of Gimoti, and Evoke cannot be certain that it will be able to
submit an NDA for Gimoti or obtain regulatory approval for or
successfully commercialize Gimoti; risks associated with
manufacturing new formulations of Gimoti for use in the PK trial;
Evoke’s dependence on third parties for the manufacture of Gimoti
as well as the conduct of the PK trial; Evoke may require
additional funding to complete the PK trial and submit the NDA, and
will require substantial additional funding to commercialize
Gimoti, and may be unable to raise capital when needed, including
to fund ongoing operations;; 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 Group
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com
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