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 a summary of
real-world data on the positive impact of GIMOTI (nasal
metoclopramide (NMCP) usage in reducing healthcare costs for
patients suffering from diabetic gastroparesis (DGP) versus
patients taking oral metoclopramide (OMCP). The full abstract
entitled “Superiority of Nasal Spray Compared to Orally
Administered Metoclopramide in Reducing Healthcare Costs for
Treating Diabetic Gastroparesis Patients,” was selected and
presented for a plenary session at the American College of
Gastroenterology (ACG) 2023 Annual Meeting in Vancouver, Canada.
The authors include Dr. David C. Kunkel, Gastroenterologist and
Associate Professor of Medicine at UC San Diego Health, Dr. Michael
Cline, Gastroenterologist at Cleveland Clinic, and was presented by
Dr. Richard McCallum, Gastroenterologist and Professor of Medicine
at Texas Tech University, El Paso.
The data describes the results of a comparative study that
highlights cost-related healthcare resource utilization data (HCRU)
in DGP patients taking GIMOTI (nasal metoclopramide) versus those
on oral metoclopramide over a six-month period. HCRU is the
description and quantification of patients’ total usage of
healthcare services such as emergency department (ED) visits,
hospitalization or how often they visit a healthcare provider in
the office. These data build on a comprehensive analysis of the
HCRU data presented by Dr. David C. Kunkel at Digestive Disease
Week (DDW) 2023 earlier this year which demonstrated a significant
reduction in healthcare resource usage in patients prescribed
GIMOTI compared with patients being prescribed oral metoclopramide.
The authors concluded that the likelihood of a DGP patient treated
with GIMOTI visiting the ED or being admitted to the hospital was
less than half that of patients treated with OMCP during the same
period.
DGP is a 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. Research shows that
patients with diabetic gastroparesis were admitted to the hospital
an average of four times per year and that approximately 30% of
patients with diabetes admitted for gastroparesis had to be
readmitted within 30 days. The cost to the patients and the
healthcare system is significant and the impact is considerable for
all parties involved. A retrospective U.S. claims study
demonstrated that, on average, patients recently diagnosed with
diabetic gastroparesis experience higher emergency room costs and
greater inpatient and outpatient care costs than diabetic patients
without gastroparesis.
For decades, oral metoclopramide has been the most common and
only FDA-approved treatment for diabetic gastroparesis. In June
2020, GIMOTI became the first FDA-approved nasal spray for patients
suffering from acute and recurrent diabetic gastroparesis, a highly
innovative formulation of metoclopramide with a route of
administrations that addresses a major limitation in oral therapies
which rely on stomach emptying to be absorbed.
With these leading-edge HRCU data in hand, this study aimed to
uncover whether reduced healthcare resource utilization would
translate to overall health care savings and reductions in costs
associated with inpatient hospitalization (IH), emergency
department (ED), hospital outpatient (HO), physician office (PO),
lab/home/telehealth (LHT), and pharmacy for DGP patients treated
with NMCP vs. OMCP.
Using the comprehensive IBM MarketScan Research Database, the
data presented at ACG 2023 highlights the actual costs incurred
over a 6-month retrospective cohort study by adult patients with
documented gastroparesis and diabetes taking either NMCP (n=45) or
OMCP (n=180). The cohorts were well matched across age, sex,
region, payer, DGP severity, and comorbidity index. Select data
points and key findings from the real-world evidence study are
outlined below:
- Over the 6-month post index period, NMCP patients/payers spent
approximately $15,000 less than OMCP patients/payers between
medical facility and pharmacy visits
- Total pharmacy costs in the NMCP cohort were numerically higher
than pharmacy costs in the generic OMCP group but were not
statistically significantly higher
- More than half of OMCP treated subjects visited the inpatient
and ED healthcare settings in the 6-month post treatment index than
those treated with NMCP (Image 1)
- NMCP patients spent only $115 in inpatient facilities versus
$10,136 spent by OMCP patients within the 6-month post-index period
(Image 2)
- Lower real-world cost for NMCP versus OMCP patients were
primarily driven by markedly reduced costs across key sites of
care: inpatient hospitalizations, hospital outpatient and ED
visits
Image 1: All-Cause HCRU visits in 6-month post-index period for
NMCP and OMCP patients
Image 2: All-Cause HRCU Costs between NMCP and OMCP patients
over 6-month post index period
Full poster presented at ACG 2023 available on Evoke investor
relations website under news and
presentations.
“This research provides compelling evidence that route of
administration matters and nasal metoclopramide should be used in
the preferred position in the treatment of patients with diabetes
and gastroparesis. The data for GIMOTI continues to reinforce those
providers can and should strive to improve outcomes for patients,”
commented Chris Quesenberry, GIMOTI Chief Commercial Officer.
“We continue to witness GIMOTI’s growing market strength amongst
all groups of interest, patients and providers primarily. With
these cost-benefit data and the recognition by payers (insurers,
PBMs, health systems) that there are no good alternatives to reduce
the debilitating symptoms and higher utilization of medical
benefits by their beneficiaries, we are confident in our ability to
improve care for patients with DGP. Patient Access is at the
forefront of our mission and with the current economic data
available to us, we believe we can expand access to GIMOTI with
less financial burden to the healthcare system,” commented David A.
Gonyer, R.Ph., Chief Executive Officer 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.
Visit www.EvokePharma.com for more information.Follow
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About EVERSANA EVERSANA® 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 X.
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 healthcare resource utilization 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
Charts accompanying this announcement are available
at
https://www.globenewswire.com/NewsRoom/AttachmentNg/bd0fa3a6-42b3-42ba-ae1f-569cdb479446
https://www.globenewswire.com/NewsRoom/AttachmentNg/05cba9f0-bf37-4037-867c-f2fa1abb65be
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