VIVUS, Inc. (Nasdaq: VVUS) (the “Company”), a biopharmaceutical
company, today announced the results of a pharmacokinetic (PK) and
pharmacodynamic (PD) study (NCT02714062) demonstrating that
Qsymia
® (phentermine and topiramate
extended-release) capsules CIV has favorable pharmacokinetic,
efficacy, and safety/tolerability profiles when used for eight
weeks to treat adolescents with obesity. The study was
conducted in order to establish dosing levels for the ongoing Phase
4 post-marketing study of Qsymia in obese adolescents. The
results have been published online in Diabetes, Obesity and
Metabolism.1
“Over the past 30 years, childhood obesity has
become an epidemic and continues to be a major public health
concern, with obesity rates currently over 18% for those between
the ages of 12 and 19 years based on U.S. government data2,” said
Daniel Hsia, MD, an adult/pediatric endocrinologist, Associate
Professor at Pennington Biomedical Research Center and lead author
on the publication. “Lifestyle-based interventions alone often show
only a modest effect on long-term weight loss, and overweight and
obese children have more comorbidities compared with children with
normal weight. Importantly, they are also five times more
likely to become overweight or obese adults and have a higher risk
of developing diabetes, hypertension, dyslipidemia, and coronary
heart disease later in adulthood. More effective treatment
modalities are urgently needed to address childhood obesity.”
This randomized, double blind,
placebo-controlled, study was conducted at four U.S. sites and
enrolled 42 participants ages 12-17 years with a body-mass index
(BMI) greater than or equal to the 95th percentile for age and
sex. The study consisted of a 14-day (maximum) screening
period followed by a 56-day treatment period. Eligible
participants were randomly assigned in a 1:1:1 ratio to placebo,
mid-dose Qsymia or top-dose Qsymia. Within each active
treatment arm, doses were titrated at two-week intervals starting
with low dose Qsymia and increasing until the randomized dose was
achieved. Participants assigned to placebo underwent a sham
titration to ensure that both participants and site personnel
remained blinded to treatment assignment. The primary objective of
the study was to describe the PK profiles of Qsymia after
administration in adolescents with obesity.
Key findings from the study include:
- The study authors conclude that both the mid- and top-doses of
Qsymia evaluated in this study are appropriate for longer-term
safety and efficacy study in adolescents.
- PK analyses were conducted in 26 patients in the Qsymia groups
(14 mid-dose and 12 top-dose), and results show that exposure to
the mid- and top-dose Qsymia groups was comparable to that observed
in prior studies of Qsymia in overweight and obese adults.
- Significant differences from baseline to Day 56 were observed
with respect to mean percentage change in weight for both Qsymia
groups compared with placebo (-3.72%, -4.96% and +1.06% for the
mid- and top-dose Qsymia groups and placebo group, respectively);
and for mean change in waist circumference and hunger scores for
the top-dose Qsymia group compared with placebo (-2.8 cm, -4.9 cm,
and +0.3 cm for the mid- and top-dose Qsymia groups and placebo
group, respectively).
- Treatment emergent adverse events were reported in 54.8% of the
42 patients who entered the trial; specific events reported by two
or more subjects included headache, paresthesia, hypoesthesia, dry
mouth, decreased appetite, and insomnia. All of these have
been observed in previous studies with Qsymia.
- Of the 42 patients enrolled, 37 (88.1%) completed the study,
indicating tolerability of Qsymia.
“These findings add to the growing body of data
supporting the safety and clinical benefit of Qsymia in diverse
patient populations,” said John Amos, Chief Executive Officer at
VIVUS. “Currently, there is only one approved weight loss
drug for patients age 12 years and older and, while it effectively
lowers BMI, its side effect profile of gastrointestinal distress
has limited its clinical use. The data reported today suggest that
Qsymia could be an important treatment option in this patient
population, and our ongoing Phase 4 trial of Qsymia, if successful,
could support label expansion to include adolescents who are
overweight or obese.”
In May 2019, VIVUS initiated a Phase 4
post-marketing study, which the U.S. Food and Drug
Administration (FDA) required as part of the approval of
Qsymia in 2012. The study is expected to enroll 200 participants 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. To date, 98 patients have been enrolled and
randomized.
References
1 Hsia DS, Gosselin N, Williams J, Farhat N,
Marier JF, Shih W, et al. A randomized, double-blind,
placebo-controlled, pharmacokinetic and pharmacodynamic study of a
fixed-dose combination of phentermine/topiramate in adolescents
with obesity. Diabetes, Obesity and Metabolism. doi:
10.1111/dom.13910.
2 Hales CM, Fryar CD, Carroll MD, Freedman DS
and Ogden CL. Trends in obesity and severe obesity prevalence in US
youth and adults by sex and age, 2007-2008 to 2015-2016. JAMA.
2018;319(16):1723-1725.
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 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. Mark Oki Chief Financial
Officeroki@vivus.com 650-934-5200 |
Investor Relations: Lazar FINN PartnersDavid
CareySenior Partner
david.carey@finnpartners.com 212-867-1768 |
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