Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty
pharmaceutical company focused primarily on treatments for
gastrointestinal (GI) diseases with an emphasis on
GIMOTI® (metoclopramide) nasal spray, announced that the
abstract entitled “Reducing Real-World Healthcare Resource
Utilization For Patients With Diabetic Gastroparesis (DGP) Treated
with Metoclopramide Nasal Spray Versus Oral Metoclopramide” will be
presented at Digestive Disease Week (DDW) 2023 taking place from
May 6-9, 2023 at the McCormick Place, Chicago.
David C. Kunkel, MD, Gastroenterologist and Associate Professor
of Medicine at University of California San Diego Health, will
deliver an oral presentation of the abstract in the AGA Clinical
Practice Section Distinguished Abstract Plenary Session at DDW on
Tuesday, May 9th at 8:20 AM CDT. The oral presentation will focus
on the impact of GIMOTI to reduce healthcare resources across
several settings, such as physician's offices visits, emergency
room visits, and inpatient and outpatient hospital stays from a
retrospective analysis of 514 diabetic gastroparesis patients
compared those receiving oral metoclopramide.
Plenary sessions at DDW are the forum for highlighting the
year’s best research abstracts that have the potential to impact
clinical practice and make a significant contribution to the field
of gastroenterology, as determined by the conference
organizers. These real-world data were selected for
presentation alongside a total of only six (6) meritorious clinical
abstracts from more than 3,500 that were submitted.
GIMOTI is the first and only FDA-approved nasal formulation of
metoclopramide commercially available and specifically designed to
deliver a non-oral dose of metoclopramide for the relief of
symptoms in adults with acute and recurrent DGP. By bypassing the
stomach and being directly absorbed in the bloodstream, GIMOTI may
provide relief to patients experiencing acute and recurrent flares,
especially nausea, vomiting and abdominal pain, which can result in
increased visits to their doctors and reliance on costly emergent
care (emergency department visits and hospitalizations).
An additional poster presentation entitled “Use of Machine
Learning to Identify Gastroparesis Patient Suitable for Nasal Spray
Metoclopramide” will be presented by Pierantonio Russo, MD, Chief
Medical Officer of EVERSANA. This study used large claims databases
and clinical features of GIMOTI-prescribed patients to predictively
model patients in the US who might be appropriate for GIMOTI based
on having similar clinical features.
In addition, Evoke Pharma will showcase their GIMOTI nasal spray
and supporting educational materials at DDW booth
#3334. Evoke encourages all attendees to visit their booth
for additional discussion to learn more about the product and its
impact on patients.
Details of the presentations are as
follows:1. AGA Distinguished
Plenary Presentation Title: “Reducing Real-World
Healthcare Resource Utilization for Patients with Diabetic
Gastroparesis (DGP) Treated with Metoclopramide
Nasal Spray Versus Oral Metoclopramide”
Presentation Date &
Time: May 9, 2023, from 8:00 AM to 9:30 AM
CDT
Presenter:
Dr. David C. Kunkel, Gastroenterologist and Associate
Professor of Medicine at UC San Diego Health
Location: McCormick Place, Chicago,
IL
2. Poster Presentation Title:
“Use of Machine Learning to Identify Gastroparesis Patient
Appropriate for Nasal Spray Metoclopramide” (Poster
Number: Su1651)
Session Date and
Time: May 7, 2023 from 12:30 PM to 1:30 PM CDT
Presenter:
Pierantonio Russo, MD, Corporate Chief Medical Officer,
EVERSANA
Location: McCormick Place, Chicago,
IL
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, commercialized and markets 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.
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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.
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 impact
of the healthcare utilization resource study for 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 risks and uncertainties inherent in Evoke’s
business, including, without limitation: Evoke’s ability to obtain,
maintain and successfully enforce intellectual property protection
for Gimoti; Evoke’s and EVERSANA’s ability to successfully drive
market demand for Gimoti; Evoke’s ability to obtain additional
financing as needed to support its operations; the COVID-19
pandemic may continue to 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
result in recalls or product liability claims; and other risks and
uncertainties 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:Daniel Kontoh-BoatengDKB
PartnersTel: 862-213-1398dboateng@dkbpartners.net
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