Evoke Pharma Announces FDA Orange Book Listing of New GIMOTI Patent
27 Novembre 2023 - 2:30PM
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 its
recently issued U.S. patent related to GIMOTI, No. 11,813,231 is
now listed in the U.S. Food and Drug Administration (FDA)
publication, “Approved Drug Products with Therapeutic Equivalence
Evaluations”, commonly known as the “Orange Book”.
The patent titled “Nasal Formulations of Metoclopramide” covers
a collection of nasal solutions of metoclopramide and its
characteristics when formulated. This new patent is now listed in
the FDA’s Orange Book and carries a patent term to 2029. The
listing of the patent in the Orange Book adds additional patent
protection for GIMOTI beyond the prior three listed patents.
“Due to our relentless efforts to continuously realize the
significant commercial potential of GIMOTI and the need for an
improved treatment solution for diabetic gastroparesis, our IP
portfolio now boasts an impressive set of patents and four FDA
Orange Book listings,” commented Matt D’Onofrio, President and
Chief Operating Officer of Evoke Pharma. “We are proud to have
achieved this milestone as we aim to redefine the standard for
gastroparesis treatment by providing GIMOTI, a direct route to
deliver medication leading to less hospitalizations than oral
metoclopramide.”
Patents listed in the Orange Book cover drugs that the FDA has
approved and deemed both safe and effective for the general
public's use. Inclusion in the book's list of patents can make
it easier for drug makers to monitor for new generic drugs that
could potentially arrive on the U.S. market and infringe on their
patents.
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.
Visit www.EvokePharma.com for more information.
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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 term
of patent protection 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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