New Pilot Clinical Study Results Demonstrate that Addition of VIVUS’ Qsymia® to Gastric Sleeve Surgery Significantly Impro...
August 20 2019 - 7:30AM
VIVUS, Inc. (Nasdaq: VVUS; the “Company”) today announced the
results of a pilot clinical study demonstrating that patients
receiving Qsymia (phentermine and topiramate extended-release (ER))
capsules CIV before and after laparoscopic sleeve gastrectomy (LSG)
surgery lost more weight and had a greater probability of achieving
a body mass index (BMI) of less than 40 compared with patients
undergoing surgery alone without anti-obesity medication (AOM). The
study was conducted at the Wake Forest School of Medicine and the
results appear in the current issue of Surgery for Obesity and
Related Diseases.
“Patients with a BMI of 50 or greater generally
benefit from bariatric surgery but have higher surgical risk and
increased perioperative morbidity compared with patients with lower
BMI,” said Jamy Ard, MD, Professor, Epidemiology and Prevention at
Wake Forest School of Medicine and lead author on the
publication. “In an effort to reduce these risks, we undertook
a pilot study to assess the feasibility and impact of using the
drug before and after LSG surgery. Study results show that patients
taking it lost significantly more weight before surgery and had
improved outcomes with respect to weight loss and BMI than those
not on AOM. This may allow more patients to avoid a secondary
surgical procedure and its attendant risks. These results should be
further evaluated in larger studies.”
In addition to increased surgical risk, patients
with a BMI of 50 or greater are likely to have a BMI of 40 or
greater even after successful surgery. Physicians often address
this issue by offering patients a two-stage weight loss process
that involves an initial LSG followed by a second surgical
procedure after initial post-LSG weight loss. Treatments that allow
patients to achieve BMI of less than 40 after the initial LSG could
reduce the need for a second surgical procedure, decreasing health
risks and costs. “Though there is no consensus from a guidelines
perspective, the use of the AOM Qsymia with a low-calorie diet
prior to LSG has the potential to decrease weight and reduce
surgical risk, while post-LSG Qsymia use could increase and
maintain the total amount of weight lost with the potential to
eliminate the need for a second surgical procedure,” said Santosh
T. Varghese, MD, Chief Medical Officer at VIVUS.
The pilot study recruited 25 participants with a
BMI of 50 or more who were planning to undergo LSG. Patients in the
control group had a BMI of 50 or more and underwent LSG in the same
timeframe (June 2014 – July 2016) but were not included in the
study protocol. Patients in the experimental arm received Qsymia at
a dose of 3.75/23 mg once daily for two weeks, which was then
increased to 7.5/46 mg or 15/92 mg daily in order to achieve the
greatest weight loss with the fewest side effects. Patients tapered
off the medication beginning two weeks prior to surgery in order to
avoid potential interactions between phentermine and anesthesia and
resumed dosing at 7.5/46 mg daily one month following LSG, with
dose adjustments made monthly over the next two months. Patients
then continued to utilize Qsymia for a 24-month period.
Key findings from the study include:
- The experimental group had a baseline BMI of 61.2 ± 7.1 kg/m2
compared with 57.0 ± 5.6 kg/m2 for control participants. At 24
months, the mean BMI was 33.8 kg/m2 for the experimental group vs.
42 kg/m2 for control participants.
- Of the 25 patients recruited, 13 completed LSG. Patients who
did not complete LSG were due to: medical complications unrelated
to Qsymia (n=2), decision not to pursue surgery (n=1),
Qsymia-related adverse events (n=3), because they were lost to
follow-up and withdrawn from the study (n=4) or opted to undergo a
surgical procedure other than LSG (n=2).
- Patients in the experimental arm lost more than twice the
weight with an average of 28.1 kg during the pre-operative period
compared with an average of 12.3 kg for those in the control
group.
- At two years post-LSG, the experimental group lost 11.2% more
of initial body weight compared with controls (p=0.007), which
translates to a -18.2% difference in percent excess weight loss
(%EWL) of favoring the experimental group.
- A higher proportion of patients in the experimental group
compared with controls achieved a BMI less than 40 at 3, 6, 12 and
24 months post-LSG (61.5% vs. 47.5% at 24 months,
respectively).
- There was a significant increase in the odds of achieving BMI
less than 40 for the experimental group compared with controls at 6
months post-LSG (odds ratio = 4.1); at 24 months the odds ratio
remained 4.1 but was no longer statistically significant.
The study authors conclude that for patients
with a BMI of 50 or more the combination of LSG and
phentermine/topiramate ER (Qsymia) had a robust impact on patients
both before and for up to two years after LSG surgery.
“This pilot study adds to the growing body of
data supporting the use of Qsymia in a variety of therapeutic
strategies for helping adults with obesity improve their BMI and
achieve more healthy weight goals,” said John Amos, Chief Executive
Officer at VIVUS. “The potential to help these patients
achieve a BMI less than 40 and potentially avoid the need for a
second surgical procedure would be an important advance in
improving outcomes while reducing risk. Additionally, the enhanced
pre-LSG weight loss in the experimental group compared with
controls further underscores the clinical benefit that Qsymia can
provide even in patients with a BMI of 50 or more.”
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 ability to execute
on our business strategy to enhance long-term stockholder value;
risks and uncertainties related to our expected future revenues,
operations and expenditures; 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.com650-934-5200
Investor Relations: Lazar PartnersDavid
CareyManaging Director dcarey@lazarpartners.com212-867-1768
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