MOUNTAIN VIEW, Calif.,
March 7, 2013 /PRNewswire/
-- VIVUS, Inc. (Nasdaq: VVUS) announced today the launch
of the Q and Me™ app, a no-cost mobile app available through iTunes
and Google Play Store designed to help patients meet their weight
loss goals. Q and Me can be used by anyone wanting to develop
skills that can lead to lasting weight loss.
The Q and Me Patient Support Program (www.QandMEsupport.com) is
designed to guide patients in incorporating proper nutrition and
physical activity into everyday life. The program provides
patients the ability to:
- Set personal weight loss and fitness goals
- Track weight, food intake/calories and physical
activities/calories burned
- Receive personalized emails providing motivation and tips
- Access easy-to-prepare recipe suggestions
The new Q and Me app for Apple and Android-based devices now
allows users to access important tools while on the go: Food
Log, Activity Log, and BMI Calculator.
"VIVUS is committed to supporting healthcare providers and
patients in their treatment of obesity," said Michael P. Miller, senior vice president and
chief commercial officer of VIVUS. "The Q and Me app can help
make the weight loss journey more manageable by empowering people
to make changes that may lead to meaningful weight loss."
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/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.
For more information, visit: www.qsymia.com.
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.
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 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 www.vivus.com.
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 home delivery pharmacy network; whether or not the FDA
approves our amendment to the REMS for Qsymia, which, if approved,
would allow dispensing through select certified 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; 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 obtain and 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 results of post-marketing studies are not
favorable; compliance with post-marketing regulatory standards is
not maintained; 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, 2012, and periodic
reports filed with the Securities and Exchange Commission.
SOURCE VIVUS, Inc.