Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
and EVERSANA™, a leading provider of global commercial services to
the life science industry, are pleased to announce the commercial
launch of Gimoti™ (metoclopramide) nasal spray for the relief of
symptoms in adults with acute and recurrent diabetic gastroparesis.
GIMOTI is specifically designed to address the
unique needs of adult patients with diabetic gastroparesis by
delivering an established treatment as a nasal spray that bypasses
the GI tract. Adults suffering from diabetic gastroparesis may have
unpredictable stomach emptying and may vomit their medications. For
these reasons, oral administration may be problematic since drug
absorption in the small intestine requires gastric emptying.
GIMOTI, which was approved by the U.S. Food and Drug Administration
in June 2020, is the first and only treatment for diabetic
gastroparesis that enters the bloodstream through the nasal
mucosa.
“Patients with diabetic gastroparesis often have
erratic absorption of orally administered drugs due to delayed
gastric emptying or are unable to keep from vomiting pills
traditionally used to treat symptoms of this disease. Unlike oral
medications, GIMOTI is administered nasally, bypassing the need for
absorption in the GI system, allowing the drug to enter the
bloodstream directly and avoiding the problem of unpredictable
stomach emptying,” stated Henry Parkman, M.D., Stanley H. Lorber
Research Endowment Fund and Chair, and Director, Gastroenterology
Motility Laboratory, School of Medicine at Temple University. “For
these patients suffering from debilitating symptoms such as nausea,
abdominal pain, bloating, early satiety, and vomiting, GIMOTI is an
important alternative to the current standard of care to help those
that suffer from this disease.”
“The commercial launch of our novel treatment
for the underserved market of patients suffering from diabetic
gastroparesis is an important milestone reflecting years of
clinical and product development,” commented David Gonyer, R.Ph.,
President and CEO of Evoke. “GIMOTI fills a major treatment gap by
providing the current standard of care treatment through a non-oral
delivery. With the support of an integrated commercial team from
EVERSANA, we are confident in our ability to address the large and
growing market opportunity. We are excited to provide patients and
their prescribing physicians with a new important treatment
option.”
Jim Lang, CEO of EVERSANA, added, “Evoke’s
innovative approach is a welcome advancement that has the ability
to change the continuum of care for treatment of adults suffering
from the symptoms of diabetic gastroparesis. Powered by a full
commercialization engine, a trained sales team will be immediately
deployed to offer this novel approach to their targeted physician
base. Patients will then get the full benefit of our access,
distribution and adherence services, optimized by real-time
analytics and actions. We look forward to commencing commercial
availability of GIMOTI and supporting seamless physician adoption
and patient access.”
IMPORTANT SAFETY INFORMATION
What is GimotiTM
(metoclopramide) nasal spray?GIMOTI is a
prescription medicine used 30 minutes before meals and at bedtime
for 2 to 8 weeks to relieve symptoms of slow stomach emptying in
adults with diabetes. Avoid treatment with metoclopramide (all
dosage forms and routes of administration) for longer than 12
weeks.
GIMOTI is not recommended for use in children under age 18.
Important facts about GIMOTIThis is a summary
of important information you need to know about GIMOTI. This
information does not take the place of talking with your healthcare
professional about your medical condition or your treatment.
What is the most important information I should know
about GIMOTI?
GIMOTI can cause serious side effects,
including: TARDIVE DYSKINESIA: Abnormal muscle
movements, mostly of the face or tongue muscles. You cannot control
these movements, and they may not go away even after stopping
GIMOTI. Your chances of getting tardive dyskinesia
increase
- The longer you take metoclopramide and the more
metoclopramide you take. You should not take GIMOTI for more than 8
weeks at a time, and you should not take products containing
metoclopramide (including GIMOTI) for more than 12 weeks at a
time.
- If you are older, especially if you are an older woman
(e.g., age 65 years and older)
- If you have diabetes
Call your healthcare professional right away if you get
movements you cannot stop or control, such as lip smacking,
chewing, or puckering up your mouth; frowning or scowling; sticking
out your tongue; blinking and moving your eyes; shaking of your
arms and legs. Do not use GIMOTI if you
- Have a history of tardive dyskinesia or have a problem
controlling your muscles and movements after taking GIMOTI or a
medicine that works like GIMOTI
- Have stomach or intestinal problems that could get worse with
GIMOTI, such as bleeding, blockage, or a tear in the stomach or
bowel wall
- Have a type of tumor that can cause high blood pressure, such
as pheochromocytoma
- Have epilepsy (seizures)
- Are allergic to metoclopramide. Stop taking GIMOTI right away
and get emergency help if you have any of these symptoms:
- swelling of your tongue, throat, lips, eyes, or face
- trouble swallowing or breathing
- skin rash, hives, sores in your mouth, or skin blisters
Before starting GIMOTI, tell
your healthcare professional about all your medical conditions,
especially if you have problems controlling your muscle movements
after taking any medicine, Parkinson’s disease, pheochromocytoma,
kidney or liver disease, depression or mental illness, high blood
pressure. Also tell your healthcare professional if you are
pregnant or plan to become pregnant, are breastfeeding or plan to
breastfeed, or drink alcohol.
Tell your healthcare professional about all the medicines you
take, including prescription drugs and over- the-counter medicines,
vitamins, and herbal supplements.
Speak with your healthcare professional before you start or stop
any other medicines.
Especially tell your healthcare
professional if you take another
medicine that contains metoclopramide, such as Reglan® tablets,
medicine for Parkinson’s disease, blood pressure medicine, medicine
for depression, especially a monoamine oxidase inhibitor (maoi),
antipsychotic medicine used to treat mental illness, such as
schizophrenia, insulin, medicines that can make you sleepy, such as
anxiety medicines, sleep medicines, and narcotics
What should I avoid while taking GIMOTI?
Do not drink alcohol while taking
GIMOTI. GIMOTI may cause
sleepiness or dizziness. Do not
drive, operate machinery, or do potentially dangerous activities
until you know how GIMOTI affects
you.
What are other possible side effects of
GIMOTI?
Other changes in muscle control and
movement,
Neuroleptic
Malignant
Syndrome,
depression,
thoughts
about
suicide,
and
suicide,
high
blood
pressure,
too
much
body
water,
and
increased
prolactin.The
most common side effects of GIMOTI include
unpleasant taste after
dosing,
headache, and
tiredness. These
are not all the possible side effects of GIMOTI.
Ask your healthcare
professional for medical advice about side
effects.
You may report side effects related to Evoke Pharma
products by calling 1-833-4-GIMOTI (1-833-444-6684) or emailing
GIMOTImedinfo@evokepharma.com. If you prefer to report these to the
FDA, either visit www.FDA.gov/medwatch or
call 1-800-FDA-1088.
Please see complete Prescribing
Information, including Boxed Warning,
Medication Guide, and
Instructions for Use.
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.
About EVERSANA Life Science Services,
LLC
EVERSANA™ is a leading provider of global
services to the life science industry. The company’s integrated
solutions are rooted in the patient experience and span all stages
of the product lifecycle to deliver long-term, sustainable value
for patients, prescribers, channel partners and payers. The company
serves more than 500 organizations, including innovative start-ups
and established pharmaceutical companies to advance life science
solutions for a healthier world. To learn more about EVERSANA,
visit eversana.com or connect through LinkedIn and Twitter.
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 size
of the gastroparesis market and the potential of GIMOTI to provide
an important new alternative to current treatment options. 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 drive market demand for GIMOTI; 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 result in recalls or product
liability claims; Evoke’s 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 GroupJan Medina,
CFATel: 646-536-7035jmedina@theruthgroup.comMedia Contact:The Ruth
GroupKirsten ThomasTel: 508-280-6592kthomas@theruthgroup.com
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