- Data from a dedicated ambulatory blood pressure study showed
once-daily treatment with GEMTESA® was not associated with
statistically significant or clinically meaningful effects on blood
pressure or heart rate
Urovant Sciences, Inc., a wholly- owned subsidiary of Sumitovant
Biopharma Ltd., announced today that the journal Blood Pressure
Monitoring has published the ambulatory blood pressure data on its
recently-approved overactive bladder (OAB) therapy, GEMTESA®
(vibegron) in the U.S. The peer-reviewed publication is currently
available online and the print article is scheduled to be published
in an upcoming issue of the journal.
In a dedicated, double-blind, placebo-controlled ambulatory
blood pressure study of patients with OAB, once-daily treatment
with GEMTESA® 75 mg was not associated with statistically
significant or clinically meaningful effects on blood pressure or
heart rate. The article is entitled, “Effects of Vibegron on
Ambulatory Blood Pressure in Patients with Overactive Bladder:
Results from a Double-Blind, Placebo-Controlled Trial.”
"The publication of this dedicated ambulatory blood pressure
study in OAB patients in a peer-reviewed cardiology journal further
supports the safety profile of GEMTESA," said co-author Cornelia
Haag-Molkenteller, MD, PhD, executive vice president and Chief
Medical Officer of Urovant Sciences. "GEMTESA does not have a blood
pressure warning in its label, which is an important consideration
for health care providers and patients.”
"This standalone study was carried out to understand the
potential effects of GEMTESA on heart rate and blood pressure based
on ambulatory blood pressure measurements," said lead author
Michael A. Weber, MD, Professor of Medicine at the State University
of New York Downstate College of Medicine, Brooklyn, NY. “The
published data substantiate that compared with placebo, GEMTESA has
no statistically significant or clinically meaningful impact on
blood pressure."
Results from Ambulatory Blood Pressure Study
The ambulatory blood pressure study enrolled 214 patients with
OAB, aged between 40-75 years. The mean age was 59.3 years and
74.6% of all patients were female. Overall, 35% of patients had
pre-existing hypertension, which was present in slightly more
patients in the GEMTESA group than in the placebo group.
Demographic characteristics were well balanced between the
groups.
The primary endpoint was change from baseline to day 28 in mean
daytime ambulatory systolic blood pressure and was evaluated
against a criterion of 3.5 mmHg for the upper limit of the
confidence interval. Key secondary endpoints were change from
baseline to day 28 in mean daytime ambulatory diastolic blood
pressure and heart rate and change from baseline to day 28 in mean
24-hour ambulatory systolic blood pressure, diastolic blood
pressure, and heart rate. Safety was assessed through adverse event
reporting and safety lab tests.
Individuals with valid 24-hour ambulatory blood pressure
readings at baseline were randomly assigned 1:1 to receive once
daily GEMTESA or placebo for 28 days. At day 28, patients returned
to the clinic after completion of a second 24-hour assessment. At
baseline, in-clinic mean baseline systolic blood pressure,
diastolic blood pressure, and heart rate were generally similar
between groups. There were no statistically significant or
clinically meaningful differences in mean daytime or mean 24-hour
ambulatory systolic blood pressure, diastolic blood pressure, or
heart rate after 28 days of treatment with GEMTESA compared with
placebo.
Serious treatment-emergent adverse events occurred in 1 patient
in each group (GEMTESA: postoperative pain; placebo: hypoglycemia).
Hypertension was the most frequently reported treatment-emergent
adverse event in both the placebo (4 patients) and the GEMTESA
treatment group (5 patients); however, no event of hypertension
with GEMTESA was considered related to study treatment. Of the 5
reported events of hypertension with GEMTESA, 1 occurred in a
patient taking phentermine, which was a prohibited medication known
to increase blood pressure.
About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs
when the bladder muscle contracts involuntarily. Symptoms may
include urinary urgency (the sudden urge to urinate that is
difficult to control), urgency incontinence (unintentional loss of
urine immediately after an urgent need to urinate), frequent
urination (usually eight or more times in 24 hours), and nocturia
(waking up more than two times in the night to urinate).1
Approximately 30 million Americans suffer from bothersome
symptoms of OAB, which can have a significant impairment on a
patient’s day-to-day activities.1, 2
About GEMTESA®
GEMTESA is a prescription medicine for adults used to treat the
following symptoms due to a condition called overactive
bladder:
- urge urinary incontinence: a strong need to urinate with
leaking or wetting accidents
- urgency: the need to urinate right away
- frequency: urinating often
It is not known if GEMTESA is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
Do not take GEMTESA if you are allergic to vibegron or
any of the ingredients in GEMTESA.
Before you take GEMTESA, tell your doctor about all your
medical conditions, including if you have liver problems; have
kidney problems; have trouble emptying your bladder or you have a
weak urine stream; take medicines that contain digoxin; are
pregnant or plan to become pregnant (it is not known if GEMTESA
will harm your unborn baby; talk to your doctor if you are pregnant
or plan to become pregnant); are breastfeeding or plan to
breastfeed (it is not known if GEMTESA passes into your breast
milk; talk to your doctor about the best way to feed your baby if
you take GEMTESA).
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. Know the medicines you take. Keep a list of
them to show your doctor and pharmacist when you get a new
medicine.
What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability
to empty your bladder (urinary retention). GEMTESA may increase
your chances of not being able to empty your bladder, especially if
you have bladder outlet obstruction or take other medicines for
treatment of overactive bladder. Tell your doctor right away if you
are unable to empty your bladder.
The most common side effects of GEMTESA include headache,
urinary tract infection, nasal congestion, sore throat or runny
nose, diarrhea, nausea, and upper respiratory tract infection.
These are not all the possible side effects of GEMTESA. For more
information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.
Please click here
for full Product Information for GEMTESA.
About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on
developing and commercializing innovative therapies for urologic
conditions. The Company’s lead product, GEMTESA®(vibegron), is an
oral, once-daily (75 mg) small molecule beta-3 agonist for the
treatment of adult patients with overactive bladder (OAB) with
symptoms of urge urinary incontinence, urgency, and urinary
frequency. GEMTESA was approved by the U.S. FDA in December 2020
and launched in the U.S. in April 2021. GEMTESA is also being
evaluated for the treatment of OAB in men with benign prostatic
hyperplasia. The Company’s second product candidate, URO-902, is a
novel gene therapy being developed for patients with OAB who have
failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned
subsidiary of Sumitovant Biopharma Ltd., intends to develop novel
treatments for additional urologic diseases. Learn more about us at
www.urovant.com.
About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging
data-driven insights to rapidly accelerate development of new
potential therapies for unmet patient conditions. Through our
unique portfolio of wholly-owned “Vant” subsidiaries—Urovant,
Enzyvant, Spirovant, Altavant—and use of embedded computational
technology platforms to generate business and scientific insights,
Sumitovant has supported the development of FDA-approved products
and advanced a promising pipeline of early-through late-stage
investigational assets for other serious conditions. Sumitovant, a
wholly-owned subsidiary of Sumitomo Dainippon Pharma, is also the
majority-shareholder of Myovant (NYSE: MYOV). For more information,
please visit our website at www.sumitovant.com or follow us on
Twitter and LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed
pharmaceutical companies in Japan, operating globally in major
pharmaceutical markets, including Japan, the U.S., China, and other
Asian countries. Sumitomo Dainippon Pharma is based on the 2005
merger between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more
than 7,000 employees worldwide. Additional information about
Sumitomo Dainippon Pharma is available through its corporate
website at https://www.ds-pharma.com.
To read our news release, visit urovant.com/news-releases.
- Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The
Burden of Overactive Bladder on US Public Health. Current bladder
dysfunction reports, 11(1), 8–13.
https://doi.org/10.1007/s11884-016-0344-9
- Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z.
S., & Milsom, I. (2011). National community prevalence of
overactive bladder in the United States stratified by sex and age.
Urology, 77(5), 1081–1087.
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version on businesswire.com: https://www.businesswire.com/news/home/20211108005435/en/
Urovant Sciences Alana Darden Powell Vice President, Corporate
Communications 949-436-3116 alana.darden@Urovant.com
media@urovant.com
Sumitovant Biopharma Maya Frutiger Vice President,
Corporate Communications media@sumitovant.com
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