Evoke Pharma Receives Conditional FDA Acceptance of Proposed Brand Name for EVK-001
July 26 2016 - 8:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that the US Food and Drug Administration (FDA) has
conditionally accepted the proprietary brand name, “Gimoti,” for
the Company’s product candidate, EVK-001 (metoclopramide nasal
spray). A request for proprietary name review for Gimoti will be
included if and when Evoke submits a New Drug Application (NDA) for
the product candidate.
The name Gimoti (pronounced “jye-MOH-tee”) was
developed in compliance with the FDA’s Guidance for Industry,
Contents of a Complete Submission for the Evaluation of Proprietary
Names (issued in February 2010). The development program,
which included research with physicians and pharmacists, as well as
an international name assessment, confirmed Gimoti is a proprietary
name with strong marketing potential that is also consistent with
the FDA’s goal of preventing medication errors and potential harm
to the public by ensuring that only appropriate proprietary names
are approved for use.
“The naming of EVK-001 as Gimoti further
demonstrates our belief that there is value in pursuing the
approval of our product candidate for the treatment of diabetic
gastroparesis in women. We are pleased to have the FDA’s
conditional approval of this brand name,” said Dave Gonyer, R.Ph.,
President and CEO. “As we consider our options to move
forward with Gimoti, we are analyzing data from our recently
completed Phase 3 trial as well as additional trials to assess
continued development opportunities for this product candidate and
all possible submission strategies. These efforts will be supported
by the recent financing we successfully completed.”
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 EVK-001, 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. EVK-001 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 the value
in continuing to pursue approval of Gimoti for the treatment of
diabetic gastroparesis in women; the marketing potential of the new
brand name; the potential for a future submission of an NDA
for the product candidate; and the Company’s ability to fund its
assessment of development opportunities for Gimoti and evaluation
of various submission strategies. 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 a number of risks and
uncertainties, including: Gimoti failed to achieve its
primary endpoint of symptom improvement in the Company’s
recently-announced Phase 3 clinical trial; Evoke is entirely
dependent on the success of Gimoti, and cannot be certain that it
will be able to identify a viable regulatory submission strategy or
otherwise conduct continued development of this product candidate;
additional analyses of data from the Phase 3 trial may produce
negative or inconclusive results, or may be inconsistent with
previously announced topline results, and may preclude submission
or approval of an NDA; the Company is seeking to negotiate a
resolution with its secured lender concerning defaults under its
credit facility and may be unable to reach acceptable terms; even
if a viable regulatory strategy is identified for Gimoti and the
defaults under the credit facility are waived, the Company will
need to continue to raise additional capital in order to complete
an NDA submission and fund its ongoing operations; and other
risks and uncertainties inherent in Evoke's business, including
those described in the Company's filings with the SEC. 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
Tel: 646-536-7009
dburke@theruthgroup.com
Media Contact:
The Ruth Group
Kirsten Thomas
Tel: 646-536-7014
kthomas@theruthgroup.com
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Apr 2023 to Apr 2024