Study Concludes That Weight Loss With Qsymia™ Significantly Improves Multiple Cardiovascular Disease Risk Factors

Study Concludes That Weight Loss With Qsymia™ Significantly Improves Multiple
                     Cardiovascular Disease Risk Factors

PR Newswire

MOUNTAIN VIEW, Calif., Feb. 1, 2013

MOUNTAIN VIEW, Calif., Feb. 1, 2013 /PRNewswire/ --VIVUS, Inc. (Nasdaq: VVUS)
announced today the publication of a study concluding that weight loss
resulting from treatment with Qsymia^TM (phentermine and topiramate
extended-release) capsules CIV led to significant improvements in cholesterol,
blood pressure and triglycerides in obese and overweight patients experiencing
one or more of these associated conditions. The improvements were
significantly greater among patients who lost 10% or more of their starting

The study was published online in The American Journal of Cardiology and can
be accessed via the following link:

"This provides clear evidence that patients with hypertension or high
cholesterol treated with Qsymia for one year experienced significant weight
loss and clinically meaningful improvements in their underlying cardiovascular
risk factors," said Suzanne Oparil, M.D., Director of the Vascular Biology and
Hypertension Program, University of Alabama at Birmingham, and an investigator
in the study. "The ability to improve underlying risk factors is another
reason physicians should proactively discuss the medical treatment of obesity
with their patients who have failed lifestyle modification alone."

Obesity is a chronic condition defined by having excess body fat. Obesity and
smoking are the leading causes of preventable death in the U.S., and obesity
contributes directly to numerous life-threatening conditions including
diabetes, cardiovascular disease, hypertension and stroke. According to the
World Health Organization and CDC, more than 500 million people worldwide and
approximately one-third of American adults (more than 78 million people) are
obese. In addition to obesity, high cholesterol, blood pressure and
triglycerides are significant risk factors for cardiovascular disease.

About the Study
Participants in the study with body mass indexes of 27 to 45 kg/m^2 were
randomized to placebo, recommended dose (7.5/46mg) or top dose (15/92mg)
Qsymia. Participants also received lifestyle modification counseling. Primary
end points were percentage weight loss and the proportion of participants
achieving at least 5% weight loss. Additional end points were changes in lipid
variables in patients with dyslipidemia and changes in blood pressure in
patients with hypertension, stratified by treatment assignment and magnitude
of weight loss. Qsymia produced significantly greater dose-related mean
percentage weight loss compared with placebo in the subgroups of participants
with dyslipidemia and those with hypertension.

In the subgroup with dyslipidemia, treatment-emergent adverse events occurred
in 75.9%, 86.5%, and 88.3% of the placebo, recommended dose, and top dose
groups, respectively. In the subgroup with hypertension, the rates were 77.3%,
85.4%, and 88.8%, respectively. The most common treatment emergent adverse
events in the subgroup with dyslipidemia and the subgroup with hypertension
were dry mouth, paraesthesia, constipation, upper respiratory tract infection,
and nasopharyngitis. Adverse event profiles in these high risk patients were
similar to those seen in the study population as a whole.

About Qsymia
Qsymia is approved in the U.S. 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/m^2 or
greater (obese) or 27 kg/m^2 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 (MAOIs); or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive ingredients in

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

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.

VIVUS is a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in obesity, sleep
apnea, diabetes and sexual health for U.S., Europe and other world markets.
Qsymia is also in phase 2 clinical development for the treatment of type 2
diabetes and obstructive sleep apnea. For more information about the company,
please visit

Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimate," "expect," "intend," "likely,"
"may," "plan," "potential," "predict," "opportunity" and "should," among
others. There are a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements. These
factors include, but are not limited to, our limited commercial experience
with Qsymia in the U.S.; the timing of initiation and completion of the
clinical studies required as part of the approval of Qsymia by the United
States Food and Drug Administration, or FDA; the response from the FDA to the
data that VIVUS will submit relating to post-approval clinical studies; the
impact of the indicated uses and contraindications contained in the Qsymia
label and the Risk Evaluation and Mitigation Strategy, or REMS, requirements;
the impact of distribution of Qsymia through a certified pharmacy network;
whether or not the FDA approves our amendment to the REMS for Qsymia, which,
if approved, would allow dispensing through select retail pharmacies to
increase access while meeting all requirements of the REMS; that we may be
required to provide further analysis of previously submitted clinical trial
data; our appeal of the negative opinion of the European Medicines Agency's,
or EMA, Committee for Medicinal Products for Human Use, or CHMP, for the
Marketing Authorization Application, or MAA, for Qsymia; our ability to
successfully commercialize or establish a marketing partnership for avanafil,
which will be marketed in the U.S. under the name STENDRA™; the ability of our
partners to maintain regulatory approvals to manufacture and adequately supply
our products to meet demand; our history of losses and variable quarterly
results; substantial competition; risks related to the failure to protect our
intellectual property and litigation in which we may become involved;
uncertainties of government or third party payer reimbursement; our reliance
on sole source suppliers; our limited sales and marketing and manufacturing
experience; our reliance on third parties and our collaborative partners; our
failure to continue to develop innovative investigational drug candidates and
drugs; risks related to the failure to obtain FDA or foreign authority
clearances or approvals and noncompliance with FDA or foreign authority
regulations; our ability to demonstrate through clinical testing the safety
and effectiveness of our investigational drug candidates; the timing of
initiation and completion of clinical trials and submissions to foreign
authorities; the volatility and liquidity of the financial markets; our
liquidity and capital resources; and our expected future revenues, operations
and expenditures. As with any pharmaceutical in development, there are
significant risks in the development, the regulatory approval, and the
commercialization of new products. There are no guarantees that the product
will receive regulatory approval outside the United States for any indication
or prove to be commercially successful. VIVUS does not undertake an obligation
to update or revise any forward-looking statements. Investors should read the
risk factors set forth in VIVUS's Form 10-K for the year ending December 31,
2011, and periodic reports filed with the Securities and Exchange Commission.


Contact: VIVUS, Inc., Timothy E. Morris, Chief Financial Officer,; Media Relations: GolinHarris, Ashley Buford,, +1-212-373-6045; Investor Relations: The Trout Group,
Brian Korb,, +1-646-378-2923
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