Evoke Announces FDA Submission of New Drug Application for Gimoti™
June 04 2018 - 7:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced the submission of its 505(b)(2) New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for Gimoti™, the Company’s nasal spray product candidate for the
relief of symptoms in adult women with acute and recurrent diabetic
gastroparesis.
“Our NDA submission for Gimoti represents a
significant step forward for Evoke and Gimoti, which has the
potential to meaningfully improve the lives of patients who suffer
from the devastating symptoms of gastroparesis,” commented Dave
Gonyer, President and CEO. “Women represent an estimated 80% of all
patients with the disease, which is characterized by debilitating
episodes of nausea, vomiting, abdominal pain and bloating
associated with delayed emptying of the stomach’s contents after
meals. Vomiting and gastric emptying delays cause unpredictable
absorption of food and oral medications which complicates glucose
control and can lead to dehydration and malnutrition. Existing oral
treatment options may be ineffective during an acute flare, which
we believe creates the need for a nonoral treatment option. Gimoti
delivers metoclopramide, a well-characterized motility and
antiemetic drug, as a nasal spray. We believe that Gimoti can make
an important difference in the lives of these patients and we look
forward to FDA approval.”
Based on FDA timelines for review of the initial
NDA submission, and Evoke’s NDA submission on Friday, June 1, 2018,
the Company expects to receive notification from FDA the filing was
accepted for substantive review in early August 2018.
Conference Call and Webcast
Evoke will hold a conference call on Monday,
June 4, 2018 at 4:30pm EST to discuss this NDA submission and
provide a corporate update. Participants should dial 1-877-407-0789
(United States) or 1-201-689-8562 (International) and mention Evoke
Pharma. A live webcast of the conference call will also be
available on the investor relations page of the Company's corporate
website at www.evokepharma.com.
After the live webcast, the event will be
archived on Evoke's website for one year. In addition, a telephonic
replay of the call will be available until June 11, 2018. The
replay can be accessed by dialing 1-844-512-2921 (United States) or
1-412-317-6671 (International) with confirmation code 13680477.
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 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
potential timing of FDA acceptance and approval, if any, of the NDA
for Gimoti; the need for a nonoral treatment option for women
suffering from gastroparesis; and the size of the patient
population. 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: the FDA may
disagree that the existing safety database and efficacy data is
sufficient to allow an NDA submission and approval, including risks
associated with Cmax falling below the bioequivalence range in the
comparative exposure PK trial and the proposed duration of use for
Gimoti being shorter as compared to the maximum approved dosing
duration for the referenced listed drug, Reglan Tablets, and the
available safety database supporting such duration; the FDA may not
agree with Evoke's interpretation of the results of clinical trials
of Gimoti; later developments with the FDA that may be inconsistent
with the already completed pre-NDA meetings; the inherent risks of
clinical development of Gimoti; Evoke is entirely dependent on the
success of Gimoti, and Evoke cannot be certain that FDA will accept
its NDA for Gimoti for substantive review or that Evoke will obtain
regulatory approval for or successfully commercialize Gimoti; Evoke
will require substantial additional funding to conduct any new
safety trials required by the FDA, 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 GroupTram BuiTel:
646-536-7035tbui@theruthgroup.com
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