VIVUS Announces FDA Approval of Qsymia REMS Modification Allowing Access Through Certified Retail Pharmacies

   VIVUS Announces FDA Approval of Qsymia REMS Modification Allowing Access
                     Through Certified Retail Pharmacies

Retail Availability Expected Within 90 Days

PR Newswire

MOUNTAIN VIEW, Calif., April 16, 2013

MOUNTAIN VIEW, Calif., April 16, 2013 /PRNewswire/ --VIVUS, Inc. (Nasdaq:
VVUS) today announced that the U.S. Food and Drug Administration (FDA) has
approved its amendment and modification to the Risk Evaluation and Mitigation
Strategy (REMS) for Qsymia^® (phentermine and topiramate extended-release)
capsules CIV. The amendment, submitted in October 2012, allows Qsymia ^ to be
dispensed through certified retail pharmacies, in addition to the existing
network of certified mail-order pharmacies.

"With FDA approval of the REMS modification, today we begin the process of
increasing the availability of Qsymia, simplifying prescribing and dispensing
and resolving the challenges associated with the mail-order-only system," said
Peter Tam, president of VIVUS. "Our goal over the next three months is to
ensure availability of Qsymia in thousands of certified retail pharmacies
nationwide. The REMS modification is a key accomplishment in removing a major
barrier that has hindered the initial acceptance of Qsymia into everyday
medical practice. We believe that retail access, along with ongoing
improvements in reimbursement, will help to accelerate Qsymia awareness, trial
and usage."

"The addition of certified retail pharmacies to the Qsymia network will reduce
the prescribing burden for physicians and the waiting times for patients
seeking to initiate therapy for obesity," said Barbara Troupin, MD, vice
president, scientific communication and risk management, VIVUS. "While the
Qsymia certified mail-order pharmacies will remain, the addition of retail
availability will improve the overall physician and patient experience."

With this modification, the goals, commitments and components of the original
Qsymia REMS will remain in place, including a Medication Guide, patient
brochure, voluntary healthcare provider training and other educational tools.
These will continue to be available as part of the modified Qsymia REMS
program. Availability at certified retail pharmacies is expected within 90
days. Until further notice, healthcare providers and patients should continue
to utilize the current certified mail-order network.

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 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 and are
subject to risks, uncertainties and other factors, including risks and
uncertainties related to the implementation of the modified REMS program and
our ability to certify and sell Qsymia through certified retail pharmacies in
the anticipated time, or at all; and risks and uncertainties related to our
ability to develop and deploy effective educational programs and
direct-to-consumer advertising that along with increased access to Qsymia and
ongoing improvements in reimbursement will result in the accelerated adoption
of Qsymia. 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's Form 10-K for the year
ending December 31, 2012, and periodic reports filed with the Securities and
Exchange Commission. VIVUS does not undertake an obligation to update or
revise any forward-looking statements.

Important Additional Information

VIVUS, its directors and certain of its executive officers may be deemed to be
participants in the solicitation of proxies from VIVUS stockholders in
connection with the matters to be considered at VIVUS's 2013 Annual Meeting of
Stockholders. VIVUS intends to file a proxy statement with the U.S. Securities
and Exchange Commission (the "SEC") in connection with any such solicitation
regarding the identity of potential participants, and their direct or indirect
interests, by security holdings or otherwise, will be set forth in the proxy
statement and other materials to be filed with the SEC in connection with
VIVUS's 2013 Annual Meeting of Stockholders. Information regarding the direct
and indirect beneficial ownership of VIVUS's directors and executive officers
in VIVUS securities is included in their SEC filings on Forms 3, 4 and 5, and
additional information can also be found in VIVUS's Annual Report on Form 10-K
for the year ended December 31, 2012, filed with the SEC on February 26, 2013,
and in VIVUS's definitive proxy statement on Schedule 14A in connection with
VIVUS's 2012 Annual Meeting of Stockholders, filed with the SEC on April 25,
2012. Stockholders will be able to obtain any proxy statement, any amendments
or supplements to the proxy statement and other documents filed by VIVUS with
the SEC for no charge at the SEC's website at Copies will also be
available at no charge at the Investor Relations section of VIVUS's corporate
website at


Contact: VIVUS, Inc., Timothy E. Morris, Chief Financial Officer,, or Financial Media Relations: Joele Frank, Wilkinson Brimmer
Katcher, Jennifer Beugelmans,, (212) 895-8692, or
Media Relations: GolinHarris, Ashley Buford,, (212)
373-6045, or Investor Relations: The Trout Group, Brian Korb,, 646-378-2923
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