United States Patent and Trademark Office (USPTO) Grants Evoke Pharma a Formulation Patent Covering GIMOTI
April 20 2023 - 8:30AM
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 United States Patent and Trademark Office
(USPTO) issued US patent No. 11,628,150 under the title “Nasal
Formulations of Metoclopramide.”
This patent expires in 2029 and covers the nasal solution of
metoclopramide and its characteristics when formulated. The
patent augments Evoke’s existing patent portfolio, which
includes U.S. Food and Drug Administration (FDA)
Orange Book-listed patents and other patents in the
EU, Japan, Canada, and Mexico. The Company will seek
to list this patent in the FDA Orange-Book in the near term.
“We view this patent approval and the others we’ve received to
date from the USPTO as evidence of the innovation behind our
product, GIMOTI and its significant contribution to the GI
community, particularly patients,” commented Matt D’Onofrio,
President & COO. “This patent will continue to protect GIMOTI’s
proprietary route of administration which is incredibly important
to our commercial efforts,” Mr. D’Onofrio concluded.
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.
Follow GIMOTI on FacebookFollow Evoke Pharma on
FacebookFollow Evoke Pharma on LinkedInFollow Evoke
Pharma on Twitter
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 and the expected inclusion of any
new patent in the FDA’s Orange Book. 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
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Apr 2024 to May 2024
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From May 2023 to May 2024