"Q AND ME" ENCOURAGES LIFESTYLE SKILLS TO AID IN LASTING WEIGHT LOSS
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:
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."
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.
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.
|Citrix Extends Line of Mobile Apps to Help Users Work More Effectively Anytime, Anywhere, on Any Device (2013/2/12)|
|Salesforce.com Launches New Salesforce Platform Mobile Services to Accelerate Mobile App Development for Every Customer Company (2013/4/9)|
|Kofax Launches Mobile Capture App for Auto Claims (2013/2/26)|
|Silicon Valley Bank Launches Mobile Banking App for Businesses (2013/3/26)|
|Providing Critical Measurement to Growing Medium, Nielsen Launches Mobile In-App Ad Resonance Solution (2013/3/6)|
|Medivo Launches Free Mobile App for Monitoring Chronic Myeloid Leukemia (CML) (2013/5/15)|
|Rackspace Launches Mobile Cloud Stacks to Accelerate Development of Mobile Apps (2013/4/9)|
|Nickelodeon Launches First Global Mobile App Inspired By Wildly Popular Teenage Mutant Ninja Turtles (2013/4/18)|
|Chester Cheetah Infiltrates App Universe With "CHEETOS Mobile App of Massive Distraction" Games (2013/2/5)|
|Trimble Launches New Mobile Apps, Website for Sportsmen (2013/3/21)|
|Start Premium Trial||Register For Free|
|P||F||Fund Financial Data (13,000+ funds)|
|P||F||Stock Financial Data (7,000+ stocks)|
|P||F||Stock and Fund Screeners (basic)|
|P||F||Investing Articles and Market Commentary|
|P||F||Articles Archive (>30 days)|
|P||F||Discuss (dozens of stock, fund, bond, and general bulletin boards)|
|P||F||Portfolio Manager (basic)|
|P||F||Morningstar Investment Classroom|
|P||F||Morningstar Investing Classroom Rewards (earn as you learn and redeem for Morningstar merchandise)|
|P||Morningstar Fund Analyst Reports (full research on 2,000 funds and ETFs)|
|P||Morningstar Stock Analyst Reports (full research on 2,000 stocks)|
|P||Morningstar Stock and Fund Stewardship Grades|
|P||Portfolio Manager (advanced with 10 x-ray analyses, including guidance)|
|P||Portfolio Monitor (monthly and on-demand personalized portfolio statements)|
|P||Morningstar Proprietary Stock Information (stock star ratings, buy/sell prices, economic moat ratings, and more)|
|P||Morningstar Stock and Fund Favorites & Red Flags eNewsletters|
|P||Premium Stock and Fund Screeners (advanced with nearly infinite ways to find the best securities for you)|
|P||Discounts on Morningstar newsletters, books, seminars, and more|
Access these features and more when you sign up for Free Membership.
Join Morningstar today. It's Free.
Access these features and more when you sign up for Premium Membership.
Start your free 14-day trial today online
Your subscription may be tax deductible. Please contact your tax advisor.