New Clinical Data Demonstrate VIVUS’ Qsymia® is Effective at Reducing Binge Eating in Patients with Binge-Eating Disorder ...
November 20 2019 - 7:30AM
VIVUS, Inc. (Nasdaq: VVUS) (the “Company”), a biopharmaceutical
company, today announced the results of a clinical study
(NCT02553824) demonstrating that patients with binge-eating
disorder (BED) or bulimia nervosa (BN) receiving Qsymia
(phentermine and topiramate extended-release (ER)) capsules CIV had
a significant reduction in binge day frequency compared with
placebo over four weeks. Additionally, Qsymia was well
tolerated in these patient populations. The study results appear
online in the International Journal of Eating Disorders.
"Dropout rates for the two pharmacologic
therapies approved for BED and BN range from 20 to 30 percent and
many patients using these medications remain symptomatic,
underscoring the need for alternative therapeutic approaches," said
Santosh T. Varghese, MD, Chief Medical Officer at VIVUS. "The
promising results announced today, along with previously reported
data from another study evaluating Qsymia in BED, suggest that
Qsymia could address an unmet treatment need in BED and BN and
support further investigation of Qsymia as a treatment option for
these serious medical conditions."
The randomized, double blind,
placebo-controlled, crossover study enrolled 22 patients (BED=18
and BN=4) who were randomized to Qsymia (n=12, 3.75/23 mg
phentermine [PHEN]/topiramate [TPM]-ER – 15 mg PHEN/92 mg TPM-ER)
or placebo (n=10) for 12 weeks. The mean baseline body mass
index for the 22 was 31.1 kg/m2. Following a two-week
washout, patients crossed over to the other arm for 12 weeks. The
primary outcome was the number of objective binge-eating (OBE) days
over four weeks; secondary outcomes included binge abstinence.
Demographics, vital signs, eating disorder behaviors, mood and side
effect data were also collected.
Key findings from the study include:
- Mean OBE days over four weeks was
16.2 at baseline and decreased to 4.2 days and 13.2 days following
Qsymia treatment and placebo, respectively (p < .0001).
- Abstinence rates were 63.6% with
Qsymia and 9.1% with placebo (p < .0001).
- Qsymia was associated with a mean
decrease in weight of 5.8 kg, compared with a mean gain of 0.4 kg
on placebo.
- There was a significant improvement
in secondary measures assessing eating disordered related
pathologies and comorbid mood symptoms and marked improvements in
depressive symptoms were also observed in patients receiving Qsymia
compared to placebo.
- No serious adverse events were
reported. Patient-reported adverse events while on Qsymia were dry
mouth (52.4% of patients), insomnia (28.6%), paresthesia (28.6%),
dysgeusia (23.8%), anxiety (14.3%), nausea, cold intolerance,
decreased appetite, dizziness, fatigue, hair loss and difficulty
finding words (9.5% each).
- Dropout rates were the same between
the Qsymia and placebo groups (9%).
- Blood pressure and heart rate
changes with Qsymia were minimal and similar to placebo.
- Responses were not significantly
different for BED versus BN.
- Binge eating returned and
abstinence rates decreased during the eight-week post-treatment
follow-up period, suggesting that additional approaches to improved
maintenance are needed.
“These data further validate the clinical
utility of Qsymia in helping patients with a variety of
weight-related health conditions to achieve healthier eating
behaviors,” said John Amos, Chief Executive Officer at VIVUS.
“A growing body of data demonstrates that Qsymia has an excellent
safety profile in diverse patient populations and that it may offer
clinical benefit across a wide spectrum of weight- and
eating-related health conditions.”
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 design and outcome of any clinical
study required by the U.S. Food and Drug Administration to expand
the Qsymia label for a binge eating indication; 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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