VIVUS, Inc. (Nasdaq: VVUS; the “Company”), a biopharmaceutical
company, today announced that the first patient has been enrolled
in a Phase four clinical study designed to evaluate the safety and
efficacy of Qsymia
® (phentermine and topiramate
extended-release) capsules CIV in obese adolescents between the
ages of 12 and 17 years (NCT# 03922945). The Centers for
Disease Control and Prevention estimates that nearly 21 percent of
adolescents ages 12 to 19 years are obese.1 A study conducted
by the World Health Organization found that obesity in children
ages five to 19 years has risen ten-fold in the past four decades
and estimates that more children globally will be overweight rather
than underweight by 2022.2
“Adolescent obesity represents one of the most
critical medical and public health issues not only because one out
of five teenagers is affected, but also due to the fact that
medical treatment options are limited,” said Aaron Kelly, PhD,
Associate Professor of Pediatrics, Co-Director of the Center for
Pediatric Obesity Medicine at the University of Minnesota, and an
investigator on the trial. “Currently only one obesity medication
for long-term use is approved for adolescents, and it is rarely
prescribed because of its modest effectiveness and often
intolerable side effects. More options are needed, and a new
clinical trial evaluating the safety and effectiveness of Qsymia in
adolescents with obesity is very important for the field of
pediatric obesity medicine.”
“Childhood and adolescent obesity is known to
impact both physical and psychological health, and increases the
risks of adult obesity, type 2 diabetes and lipid disorders,” said
Santosh T. Varghese, MD, Chief Medical Officer at VIVUS. “If this
trial is successful, Qsymia could play an important role in helping
obese adolescents achieve healthier weight goals.”
The Phase four post-marketing study, which the
U.S. Food and Drug Administration (FDA) required as part of the
approval of Qsymia in 2012, is expected to enroll 200 patients at
approximately 20 clinical sites in the United States. The
primary endpoint of the randomized, double blind,
placebo-controlled, parallel-design study is the mean percentage
change in body-mass index (BMI) in patients randomized 1:1:2 to
daily mid- or top-dose Qsymia compared with placebo over 56 weeks
of treatment. Participants will also be instructed to follow
a reduced-calorie diet and to implement a family-based lifestyle
modification program that includes physical activity, behavioral
change and family support. Safety and tolerability of Qsymia will
also be assessed.
“A previously completed pharmacokinetic (PK)
study of Qsymia in obese adolescents showed PK parameters
consistent with those observed in the clinical trials conducted in
obese adults,” said John Amos, Chief Executive Officer at
VIVUS. “These findings provide a strong rationale for
evaluating the safety and efficacy of Qsymia in this patient
population. Qsymia has demonstrated significant clinical
benefits in the treatment of obese and overweight adults. If
successful, this Phase four study could position Qsymia as an
important new treatment option for millions of adolescents
struggling with the near- and long-term challenges of
obesity.”
The Company expects to report top-line results from this Phase
four trial in the second half of 2020.
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 the Company, 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, or our current or potential partners’, ability to
successfully commercialize Qsymia; 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, or FDA; 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 our ability to work with FDA to
significantly reduce or remove the requirements of the clinical
post-approval cardiovascular outcomes trial, or CVOT; 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, or REMS, requirements; risks
and uncertainties related to the impact of any possible future
requirement to provide further analysis of previously submitted
clinical trial data; and risks and uncertainties related to our
dialog with the European Medicines Agency, or EMA, relating to the
U.S.-based CVOT for Qsymia, and the resubmission of an application
for the grant of a marketing authorization to EMA, the timing and
scope of such resubmission, if any, the results of any required
CVOT, the assessment by EMA of the application for marketing
authorization, and their agreement with the data from any required
CVOT and ultimately the decision of the European Commission whether
to grant marketing authorization for Qsymia in the EU. 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 Partners |
Mark Oki |
|
David Carey |
Chief Financial Officer |
|
Managing Director |
oki@vivus.com |
|
dcarey@lazarpartners.com |
650-934-5200 |
|
212-867-1768 |
1 Centers for Disease Control and Prevention. Childhood Obesity
Facts. Prevalence of Childhood Obesity in the United States.
Available at: https://www.cdc.gov/obesity/data/childhood.html
2 NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in
body-mass index, underweight, overweight, and obesity from 1975 to
2016: a pooled analysis of 2416 population-based measurement
studies in 128.9 million children, adolescents, and
adults. Lancet 2017;390:2627-42.
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