Evoke Pharma Announces Positive Non-Clinical Pre-NDA Meeting with FDA for Gimoti
September 07 2016 - 8:30AM
Evoke Pharma, Inc. (Nasdaq:EVOK) (the “Company"), a specialty
pharmaceutical company focused on treatments for gastrointestinal
diseases, today announced that it has completed a pre‑New Drug
Application (NDA) meeting with the U.S. Food and Drug
Administration (FDA) regarding its lead product candidate, Gimoti™,
its patented nasal delivery formulation of metoclopramide for the
relief of symptoms associated with acute and recurrent diabetic
gastroparesis in adult women. The focus of this pre-NDA meeting
with the FDA was the content of the regulatory, chemistry,
manufacturing, and control (CMC), and non-clinical sections of the
Company’s planned 505(b)(2) NDA for Gimoti.
Prior to the pre-NDA meeting, Evoke submitted an
information package describing the proposed content and format of
the regulatory, CMC, and non-clinical sections of the Gimoti NDA.
The subsequent face-to-face pre-NDA meeting afforded Evoke the
opportunity to gain further understanding of the FDA’s expectations
regarding these key sections of the NDA.
Based on the FDA’s response to the information
package and the pre-NDA meeting discussion, Evoke believes it now
has the information needed to complete these sections of the NDA in
a manner that will be acceptable for the FDA's review of the
complete package.
“We are pleased to have begun discussions with the
Agency regarding our proposed NDA submission for Gimoti utilizing
the 505(b)(2) pathway. We had a very productive meeting and this
portion of our data package was well-received,” Dave Gonyer, R.Ph.,
President and CEO, stated. “Additionally, it was agreed that Evoke
will request to meet with the FDA again in the near future to
discuss the clinical data that will comprise the remaining sections
of the NDA.”
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," "or 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: potential
NDA submission and regulatory pathway for Gimoti, including Evoke’s
belief that the sections of the NDA regarding the regulatory, CMC
and non-clinical information will be acceptable to the FDA; the
timing, if any, of an additional pre-NDA meeting with the FDA to
discuss the clinical sections of the NDA; and the potential for
regulatory approval and commercialization of Gimoti. 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 risk and uncertainties inherent in Evoke's
business, including, without limitation: additional analyses of
data from the Phase 3 trial may produce negative or inconclusive
results and may not serve as the basis for an NDA submission or
regulatory approval; the final FDA minutes may be inconsistent with
Evoke’s understanding of the FDA’s position on the matters
addressed at the meeting, or may be inconsistent with previously
announced topline results; 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
conduct additional trials of Gimoti or obtain regulatory approval
for or successfully commercialize Gimoti; Evoke will require
substantial additional funding to continue to develop and
commercialize Gimoti, and may be unable to raise capital when
needed, including to fund ongoing operations; Evoke may not be able
to successfully commercialize Gimoti, if approved, as a result of
risks associated with market acceptance, coverage and reimbursement
and competing products; 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
David Burke
O: 646-536-7009
C: 917-618-2651
dburke@theruthgroup.com
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