VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company, today
announced the publication of a new study from the Toolbox Trial
(NCT01922934), a real-world clinical trial conducted in urban
safety-net primary care clinics offering patients a “toolbox” of
cost-effective weight management tools. The study, published in the
Journal of General Internal Medicine1 (JGIM), found that a higher
proportion of subjects who initially selected Qsymia from the
toolbox or added it to their weight management plans during the
study period achieved at least a 5% weight loss compared with
subjects who never used Qsymia.
“Despite the known health benefits of
maintaining a healthy weight, many patients do not receive ongoing
counsel and access to cost-effective weight management tools,” said
Daniel Bessesen, MD, Professor of Medicine, Division of
Endocrinology, Metabolism and Diabetes, University of Colorado,
School of Medicine and the principle investigator and senior author
on the study. “The Toolbox Trial was designed to provide insight
into treatment choices and outcomes when patients are offered a
variety of low out-of-pocket cost weight management options. The
finding that more patients who included a weight loss medication in
their weight management plans (almost all of whom chose Qsymia as
their medication option compared with phentermine) achieved at
least 5% weight loss provides additional support for the use of
pharmacotherapy in helping patients achieve and maintain a healthy
weight in real-world settings.”
About the Toolbox TrialThe
Toolbox Trial was a 12-month real-world, open-label, single
institution intervention study with a registry-based comparator
group that offered patients with obesity a toolbox of weight
management services for $5 or $10 per month. The services included
partial meal replacement, recreation center membership,
phentermine, Qsymia, Weight Watchers vouchers and group behavioral
weight loss program. At the start of the trial, each patient
selected one tool. At each monthly visit, patients had the option
of continuing with the initial tool selected or switching to a
different tool. After six months, patients could pay an additional
$5 per month to add recreation center vouchers or a behavioral
weight loss program. The trial was conducted in primary care
clinics at Denver Health, an urban safety-net healthcare
organization serving a low-income, ethnically diverse population.
The primary outcome was at least 5% weight loss at 12 months. There
were 305 intervention-eligible participants, of which 119 selected
and paid for a tool.
Key findings from the study include:
- Significantly more intervention-eligible patients than
comparators achieved the primary endpoint (23.3% vs. 15.7%,
p<0.001).
- Of the 113 patients who were on treatment, 34.5% achieved the
primary endpoint.
- Of the 119 patients who selected and paid for a tool, initial
selections were meal replacements (35.3%), weight loss medication
(28.6%, including 33 subjects, or 27.7%, who chose Qsymia),
recreation center membership (21.8%), Weight Watchers vouchers
(6.7%), group behavioral weight loss program (5.9%) and ongoing
contact (1.7%).
- More than half (56.3%) of patients switched tools at least once
and 29.4% added a second tool at six months.
- The proportion of patients selecting Qsymia increased over
time, while the proportion of patients using meal replacements or
recreation center passes declined.
- A higher proportion of patients who added a second tool or ever
used Qsymia during the study achieved the primary endpoint compared
with those who never used Qsymia.
- The proportion of intervention-eligible and on-treatment
patients who achieved the primary endpoint was higher than the
comparator group who received usual care.
These findings build on an earlier study from the Toolbox Trial
published in 2018 in Obesity Journal2, which found that education
about the relative effectiveness of the weight-loss tools within
the primary care setting as well as direct experience with patients
using these medications, resulted in physicians giving higher
effectiveness ratings to weight loss medications. In this study,
PCPs from the four intervention clinics (PCP-I) as well as PCPs
from the five control clinics (PCP-C) who were part of the Toolbox
Trial completed pre- and post-trial surveys on weight-loss
counseling, comfort discussing obesity treatments and perceived
effectiveness of weight loss interventions. PCP-I received updates
on their patients who were participating in the trial and education
about weight loss medication, while PCP-C did not receive this
information. The key finding from this study was that providers
initially overvalued exercise and undervalued weight-loss
medications in the treatment of obesity, and that providers who
were exposed to education and patient experience gave higher
comfort and effectiveness ratings to weight loss medications.
“These two studies highlight the significant
market opportunity for Qsymia and provide important insight into
the types of physician education and patient outreach initiatives
required to educate stakeholders about Qsymia’s role in helping
individuals who are overweight or obese achieve and maintain a
healthy weight,” said John Amos, Chief Executive Officer at VIVUS.
“We are evaluating how to incorporate these insights into the VIVUS
Health Platform and the Qsymia Advantage Program. Our goal is to
provide individuals who are overweight or obese with an integrated
weight management strategy that integrates nutrition science,
pharmaceutical science and technology and is optimized for
long-term success in achieving and maintaining a healthy
weight.”
References
1 Saxon DR, Chaussee EL, Juarez-Colunga E, Tsai
AG, Iwamoto SJ, Speer RB, et al. A toolbox approach to obesity
treatment in urban safety-net primary care clinics: a pragmatic
clinical trial. J Gen Intern Med. 2019;34(11):2405-2413.
2 Iwamoto S, Saxon D, Tsai A, Leister E, Speer
R, Heyn H, et al. Effects of education and experience on primary
care providers’ perspectives of obesity treatments during a
pragmatic trial. Obesity Journal. 2019;26(10):1532-1538.
About Qsymia
Qsymia is approved in the United
States and is indicated as an adjunct to a reduced-calorie
diet and increased physical activity for chronic weight management
in adults with an initial body mass index (BMI) of 30 kg/m2 or
greater (obese) or 27 kg/m2 or greater (overweight) in the
presence of at least one weight-related medical condition such as
high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity
and mortality has not been established. The safety and
effectiveness of Qsymia in combination with other products intended
for weight loss, including prescription and over-the-counter drugs,
and herbal preparations, have not been established.
Important Safety
Information
Qsymia (phentermine and topiramate
extended-release) capsules CIV is contraindicated in pregnancy; in
patients with glaucoma; in hyperthyroidism; in patients receiving
treatment or within 14 days following treatment with monoamine
oxidase inhibitors; or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive
ingredients in Qsymia.
Qsymia can cause fetal harm. Females of
reproductive potential should have a negative pregnancy test before
treatment and monthly thereafter and use effective contraception
consistently during Qsymia therapy. If a patient becomes pregnant
while taking Qsymia, treatment should be discontinued immediately,
and the patient should be informed of the potential hazard to the
fetus.
The most commonly observed side effects in
controlled clinical studies, 5% or greater and at least 1.5 times
placebo, include paraesthesia, dizziness, dysgeusia, insomnia,
constipation, and dry mouth.
About VIVUS
VIVUS is a biopharmaceutical company
committed to the development and commercialization of innovative
therapies that focus on advancing treatments for patients with
serious unmet medical needs. For more information about VIVUS,
please visit www.vivus.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995 and are subject to risks, uncertainties and other factors,
including risks and uncertainties related to our ability to execute
on our business strategy to enhance long-term stockholder value;
risks and uncertainties related to our ability to address our
outstanding balance of the convertible notes due in May 2020; risk
and uncertainties related to the timing, strategy, structure and
success of our capital raising efforts; risks and uncertainties
related to our expected future revenues, operations and
expenditures; risks and uncertainties related to the impact of the
indicated uses and contraindications contained in the Qsymia label
and the Risk Evaluation and Mitigation Strategy requirements; risks
and uncertainties related to the timing of initiation and
completion of the post-approval clinical studies required as part
of the approval of Qsymia by the U.S. Food and Drug Administration
(“FDA”), including the Phase 4 post-marketing study of Qsymia in
obese adolescents; risks and uncertainties related to the response
from FDA to any data and/or information relating to post-approval
clinical studies required for Qsymia; risks and uncertainties
related to the impact of any possible future requirement to provide
further analysis of previously submitted clinical trial data; risks
and uncertainties related to the design and outcome of any clinical
study required by FDA to expand the Qsymia label; risks and
uncertainties related to our, or our current or potential
partners’, ability to successfully commercialize Qsymia; and risks
and uncertainties related to our ability to sell through the Qsymia
retail pharmacy network and the Qsymia Advantage Program. These
risks and uncertainties could cause actual results to differ
materially from those referred to in these forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. Investors should read the risk factors
set forth in VIVUS’ Form 10-K for the year ended December 31, 2018
as filed on February 26, 2019, and periodic reports filed with the
Securities and Exchange Commission. VIVUS does not undertake
an obligation to update or revise any forward-looking
statements.
VIVUS, Inc. |
Investor Relations: Lazar FINN Partners |
Mark Oki |
David Carey |
Chief Financial Officer |
Senior Partner |
oki@vivus.com |
david.carey@finnpartners.com |
650-934-5200 |
212-867-1768 |
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