Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that the U.S. Food and Drug Administration (FDA)
has approved the New Drug Application (NDA) for GIMOTI™
(metoclopramide) nasal spray, the first and only
nasally-administered product indicated for the relief of symptoms
in adults with acute and recurrent diabetic gastroparesis.
“We are extremely pleased to have received FDA
approval to commercially market GIMOTI in the United States. This
approval represents the first novel pharmaceutical treatment for
gastroparesis in several decades. Many times, patients do not
experience adequate relief of their gastroparesis symptoms from
current treatments, representing a significant need for a new
approach to therapy. We are excited to be able to offer health care
providers and their patients a unique non-oral treatment option to
relieve symptoms and help improve their quality of life,” said
David Gonyer, R.Ph., President and CEO.
“Patients with gastroparesis suffer from
characteristic symptoms such as nausea, abdominal pain, bloating,
early satiety as well as vomiting which can be severe and
debilitating. These patients often have erratic absorption of
orally administered drugs due to delayed gastric emptying,” stated
Henry Parkman, MD, Stanley H. Lorber Research Endowment Fund and
Chair, and Director, Gastroenterology Motility Laboratory, School
of Medicine at Temple University. “Unlike oral medications, GIMOTI
is administered nasally, bypassing the diseased GI track, allowing
the drug to enter the bloodstream directly and therefore may
provide predictable delivery of the therapy.”
“Together with our partner EVERSANA, we are now
fully focused on executing our commercialization strategy for
GIMOTI by leveraging EVERSANA’s integrated suite of capabilities
and highly experienced sales and marketing team,” continued David
Gonyer, R.Ph. “We anticipate initiating commercial sales in the
fourth quarter of 2020.”
The FDA approval of GIMOTI allows Evoke to
access its existing $5 million line of credit from EVERSANA to
support manufacturing and other aspects of GIMOTI’s
commercialization. As of May 31, 2020, the Company’s cash and cash
equivalents were approximately $4.7 million. Evoke believes, based
on its current operating plan, that its cash and cash equivalents,
together with the EVERSANA line of credit, will support the
company’s operations into 2021, without consideration of potential
GIMOTI revenue.
About GIMOTI™ (metoclopramide) nasal
sprayGIMOTI is indicated for the relief of symptoms in
adults with acute and recurrent diabetic gastroparesis.
Important Safety
InformationWARNING: TARDIVE
DYSKINESIA
- Metoclopramide can cause
tardive dyskinesia (TD), a serious movement disorder that is often
irreversible. The risk of developing TD increases with duration of
treatment and total cumulative dosage.
- Discontinue GIMOTI in
patients who develop signs or symptoms of TD. In some patients,
symptoms may lessen or resolve after metoclopramide is
stopped.
- Avoid treatment with
metoclopramide (all dosage forms and routes of administration) for
longer than 12 weeks because of the increased risk of developing TD
with longer-term use.
GIMOTI is not recommended for use in:
- Pediatric patients due to the risk
of developing tardive dyskinesia (TD) and other extrapyramidal
symptoms as well as the risk of methemoglobinemia in neonates.
- Moderate or severe hepatic
impairment (Child‑Pugh B or C), moderate or severe renal impairment
(creatinine clearance less than 60 mL/minute), and patients
concurrently using strong CYP2D6 inhibitors due to the risk of
increased drug exposure and adverse reactions.
GIMOTI is contraindicated:
- In patients with a history of
tardive dyskinesia (TD) or a dystonic reaction to
metoclopramide.
- When stimulation of
gastrointestinal motility might be dangerous (e.g., in the presence
of gastrointestinal hemorrhage, mechanical obstruction, or
perforation).
- In patients with pheochromocytoma
or other catecholamine-releasing paragangliomas. Metoclopramide may
cause a hypertensive/pheochromocytoma crisis, probably due to
release of catecholamines from the tumor.
- In patients with epilepsy.
Metoclopramide may increase the frequency and severity of
seizures.
- In patients with hypersensitivity
to metoclopramide. Reactions have included laryngeal and glossal
angioedema and bronchospasm.
Potential adverse reactions associated with
metoclopramide include: Tardive dyskinesia (TD), other
extrapyramidal effects (EPS), parkinsonism symptoms, motor
restlessness, neuroleptic malignant syndrome (NMS), depression,
suicidal ideation and suicide, hypertension, fluid retention,
hyperprolactinemia, effects on the ability to drive and operate
machinery.
Most common adverse reactions (≥5%) for GIMOTI
are: dysgeusia, headache, and fatigue.
These are not all of the possible side effects
of GIMOTI. Call your doctor for medical advice about whether you
should take GIMOTI and the possible risk factors and side effects.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
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 developed GIMOTI, a nasal spray formulation of
metoclopramide, for the relief of symptoms associated with acute
and recurrent diabetic gastroparesis in adults.
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 GI
symptoms as well as other systemic complications. The gastric delay
caused by gastroparesis can compromise absorption of orally
administered medications. Prior to FDA approval to commercially
market GIMOTI, metoclopramide was only available in oral and
injectable formulations and remains the only drug currently
approved in the United States to treat gastroparesis. Visit
www.EvokePharma.com for more information.
Safe Harbor StatementEvoke
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 timing of the commercial launch of GIMOTI
and commercial activities to be conducted by EVERSANA; the size of
the gastroparesis market and the potential of GIMOTI to provide an
important new alternative to current treatment options; and Evoke’s
projected cash runway and potential to access the EVERSANA line of
credit. 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’s and
EVERSANA’s ability to successfully launch and drive market demand
for GIMOTI and the timing thereof; Evoke’s ability to obtain
additional financing as needed to support its operations, including
through the EVERSANA line of credit which is subject to certain
customary conditions; the COVID-19 pandemic may disrupt Evoke’s and
EVERSANA’s business operations impairing the ability to
commercialize GIMOTI and Evoke’s ability to generate any product
revenue; Evoke’s dependence on third parties for the manufacture of
GIMOTI; Evoke is entirely dependent on the success of GIMOTI;
inadequate efficacy or unexpected adverse side effects relating to
GIMOTI that could delay or prevent commercialization, or that could
result in recalls or product liability claims; our ability to
obtain and maintain intellectual property protection for GIMOTI;
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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