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,
and EVERSANA™, a leading provider of global commercial
services to the life science industry, announced the details
of its presentation at Digestive Disease Week (DDW) 2023
demonstrating that GIMOTI reduces healthcare resource utilization
for patients with diabetic gastroparesis versus patients on oral
metoclopramide.
Selected by DDW leadership for presentation alongside a total of
only six (6) meritorious clinical abstracts from more than 3,500
that were submitted, Dr. David C. Kunkel, Gastroenterologist and
Associate Professor of Medicine at UC San Diego Health,
delivered the data to the AGA Distinguished Plenary Session. The
study, guided by Dr. Kunkel and supported by EVERSANA’s Real World
Evidence team, confirmed a hypothesis that improved symptom control
in diabetic gastroparesis (DGP) patients treated with nasal
metoclopramide would result in lower healthcare resource
utilization (HCRU) compared to patients on oral metoclopramide.
HCRU is the description and quantification of patients’ total usage
of healthcare services such as hospitalization or how often they
visit their physician in office.
Diabetic gastroparesis is an intermittent chronic disorder of
the stomach characterized by delayed gastric emptying and a range
of symptoms, including nausea, vomiting, early satiety, bloating,
and abdominal pain, which drastically reduce a patient’s quality of
life and can impair absorption of oral medications. According to a
2020 report, DGP patients experience three times greater emergency
department (ED) costs, three times greater inpatient admission
costs, and two times greater outpatient costs compared to
non-gastroparesis patients.
Given this debilitating condition places significant burden on
patients and insurance payers, the researchers who conducted the
study sought to compare the frequency of physician office,
outpatient facility, ED, and inpatient hospital visits for patients
with DGP treated with nasal metoclopramide (NMCP) versus oral
metoclopramide (OMCP). Select data points and key
findings from the real-world data analysis are outlined below:
- Cohorts were selected from patients prescribed NMCP and from
within a national database of 100 million patients of those
receiving OMCP; these groups were statistically matched using a
propensity score with 257 subjects in each
category for a total of 514 patients.
- 77% of patients were female.
- 31.1% of subjects in both groups experienced
an ED visit or inpatient hospitalization during the 6-months prior
to index.
- Patients treated with NCMP had 99 fewer
physician office visits, 1 additional outpatient
visit, 34 fewer inpatient hospitalizations and
84 fewer ED visits for DGP-related
causes in the 6 month follow up period (image 1).
- Patients treated with NMCP had 124 fewer
physician office visits, 55 fewer outpatient
facility visits, 37 fewer inpatient
hospitalizations, and 167 fewer ED visits
for any cause in the 6-month follow-up period
(image 2).
- Statistically, the likelihood of a patient treated having a DGP
related physician office visit was 36% lower in
the NMCP cohort (image 3). Similarly, for inpatient
hospitalizations and emergency department visits the likelihood was
68% and 60% lower, respectively, for NMCP-treated
patients versus OMCP.
Image 1:
Image 2:
Image 3:
Conclusions:
- In a matched comparison, NMCP-treated patients had
significantly fewer nausea and vomiting or DGP-related office
visits, ED visits, and inpatient hospitalizations in the 6 months
following start of therapy.
- The reduction in DGP-related HCRU equated to an avoidance of 99
physician office visits, 84 fewer ED visits, and 34 fewer inpatient
hospitalizations for NMCP patients versus OMCP patients in a
6-month period.
- Overall, the likelihood of a DGP patient treated with NMCP
visiting the ED or being admitted to the hospital was less than
half that of patients treated with OMCP during the same
period.
Full data presentation at DDW 2023 available on Evoke Pharma
website:
https://investor.evokepharma.com/static-files/d45f574f-699a-48bd-86f1-85d6883eedb0
Lead author Dr. David C. Kunkel, Gastroenterologist and
Associate Professor of Medicine at UC San Diego Health
commented, “This unique data set asserts that the route of
metoclopramide administration is imperative for successful DGP
treatment. The positive effects of nasal metoclopramide versus oral
metoclopramide on patients and healthcare resources is worth noting
and encouraging for the GI motility community. Considering the need
for a more effective DGP therapy, it is important to utilize a
treatment that can be absorbed by the patient, so it can work, such
as GIMOTI.”
“The consistency of data on the GIMOTI
experience amongst patients and providers including this DDW
presentation is deeply important to inform the healthcare community
and mirrors anecdotal descriptions of successful treatments we’ve
received from physicians recently. We strongly believe GIMOTI has
the potential to be the standard of care for DGP treatment,”
commented Matt D’Onofrio, President and COO of Evoke Pharma.
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 EVERSANAEVERSANA™ is a leading
independent provider of global services to the life sciences
industry. The company’s integrated solutions are rooted in the
patient experience and span all stages of the product life cycle to
deliver long-term, sustainable value for patients, prescribers,
channel partners and payers. The company serves more than 650
organizations, including innovative start-ups and established
pharmaceutical companies, to advance life sciences solutions for a
healthier world. To learn more about
EVERSANA, visit eversana.com or connect
through LinkedIn and 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 http://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: GIMOTI’s
potential to reduce HCRU by diabetic gastroparesis patents; and
Evoke’s belief that GIMOTI can improve treatment of diabetic
gastroparesis. 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, maintain and successfully enforce
intellectual property protection for GIMOTI; the results of market
research studies may not predict acceptance by patients, healthcare
providers or payors; inadequate efficacy or unexpected adverse side
effects relating to GIMOTI that could result in recalls or product
liability claims; Evoke’s ability to obtain additional financing as
needed to support its operations; Evoke is entirely dependent on
the success of GIMOTI; Evoke’s dependence on third parties for the
manufacture of GIMOTI; 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
EVERSANA Contact:Sarah ZwickyTel:
414-434-4691sarah.zwicky@eversana.com
Infographics accompanying this announcement are
available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/b50d0557-de3d-45ab-aa23-a3b6c5514cba
https://www.globenewswire.com/NewsRoom/AttachmentNg/adc9db7b-c5b6-4eca-8a13-0ddcaf78d1c5
https://www.globenewswire.com/NewsRoom/AttachmentNg/cdafc0c6-02ad-40a8-ba70-a65fa372f7b1
Evoke Pharma (NASDAQ:EVOK)
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Evoke Pharma (NASDAQ:EVOK)
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