Study Finds Significant Improvements In Patients With Obstructive Sleep Apnea Treated With Phentermine And Topiramate Extended

Study Finds Significant Improvements In Patients With Obstructive Sleep Apnea
      Treated With Phentermine And Topiramate Extended-Release Capsules

PR Newswire

MOUNTAIN VIEW, Calif., Nov. 12, 2012

MOUNTAIN VIEW, Calif., Nov. 12, 2012 /PRNewswire/ --VIVUS, Inc. (NASDAQ:
VVUS) today announced that a study published in the journal SLEEP (2012;
35(11):1529-1539) found that patients with moderate to severe obstructive
sleep apnea (OSA) taking phentermine and topiramate extended-release capsules
achieved significant improvements in key measures of OSA and cardiovascular
risk factors along with weight loss during the 28-week trial.

OSA is a chronic and potentially serious sleep disorder in which breathing is
abnormally shallow ("hypopnea") or stops altogether ("apnea") for at least 10
seconds. These repetitive events are associated with collapse of the upper
airway during sleep, and may occur 5 to 30 or more times per hour. Although
many cases are unrecognized, symptoms may include snoring, fatigue or
sleepiness during the day.

OSA afflicts approximately 3% to 7% of the U.S. population.Data from the
Wisconsin Cohort Study indicate that the prevalence of OSA in people aged
30-60 years is 9-24% for men and 4-9% for women.

OSA is associated with an increased risk of hypertension, cardiovascular
disease, myocardial infarction, stroke and increased mortality.

The current standard of care treatment for OSA is "positive airway pressure"
(PAP) in which the upper airway is kept open by increased air pressure, but
PAP provides benefits only when used consistently. Many patients find PAP to
be inconvenient or uncomfortable, and compliance with PAP treatment limits its

A safe and effective pharmacologic treatment for OSA could be useful and more
acceptable to some patients than PAP, but no drug is currently approved to
treat OSA.

In the study recently reported in SLEEP, 45 obese adults who were not using
PAP were randomized to placebo or treatment with phentermine and topiramate
extended-release capsules ^ for 28 weeks. Both groups received intensive
lifestyle modification counseling. The primary endpoint was change in the
apnea-hypopnea index (AHI), a measure of the average number of breathing
interruptions per hour during sleep. An AHI of 5-15 is considered mild, 15-30
moderate, and severe if >30. The average AHI at baseline in both treatment
groups was about 45, indicating that, on average, subjects had severe OSA at
the beginning of the study.

By the end of the study, the number of apnea-hypopnea events in the
phentermine and topiramate extended-release capsules group was reduced from an
average of 44 events per hour (severe) to 14 events per hour (mild) at Week
28. The placebo-adjusted LS mean change Week 28 was -14.9 (p=0.0084).

Cardiovascular and metabolic risk factors, such as systolic blood pressure and
mean overnight oxygen saturation, were also improved during the study.

At Week 28, the LS mean percent change in weight from baseline was -10.3% in
the phentermine and topiramate extended-release capsules group and -4.2% in
the placebo group (p=0.0006) in which subjects received only lifestyle
modification counseling. More subjects in the phentermine and topiramate
extended-release capsules group (54.5%) achieved at least 10% weight loss
compared with 13.0% in the placebo group (p=0.0044).

The most common adverse events reported during the study included dry mouth,
altered taste, sinusitis, and upper airway infection.

"Obstructive sleep apnea is a serious condition associated with potentially
deadly cardiovascular and metabolic events for the more than 15 million
patients living with the disease. Unfortunately, there are no drug treatments
available for the condition, and because current treatment options are limited
to devices or surgery, patient compliance is low," stated David Winslow, MD.,
the principal investigator of the study and lead author of the paper. "These
positive data, from what is considered a sizable study for OSA, are exciting
for those of us in the medical community treating obese patients with this

This randomized, placebo-controlled, proof-of-concept study suggests that
phentermine and topiramate extended-release capsules combined with lifestyle
modification may be useful in the treatment of patients with obstructive sleep
apnea who are unable to use PAP therapy. Additional and larger studies are
required to explore these results more thoroughly.

Phentermine and topiramate extended-release capsule is not approved for the
treatment of obstructive sleep apnea. This study was funded by VIVUS, Inc.


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 lack of 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 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™, or our partner's ability to obtain and maintain regulatory approval
to manufacture and adequately supply avanafil 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 commercialization of new products. There are no guarantees that
our products 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' 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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