| By PR Newswire | Article Rating: |
|
| March 7, 2013 07:01 AM EST | Reads: |
612 |
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.
Published March 7, 2013 Reads 612
Copyright © 2013 SYS-CON Media, Inc. — All Rights Reserved.
Syndicated stories and blog feeds, all rights reserved by the author.
More Stories By PR Newswire
Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.
- Cloud People: A Who's Who of Cloud Computing
- Enterasys Spotlights SDN's Impact on Traditional Networking in Upcoming Webinar
- NASA's Twitter Account Wins Back-To-Back Shorty Awards
- Google Compute enters the IaaS market
- GoBank Announces Timing of General Availability and National Distribution Relationships at FinovateSpring
- MicroStrategy Announces General Availability of MicroStrategy 9.3.1
- MicroStrategy Announces General Availability of MicroStrategy 9.3.1
- Cloud Expo | Maximizing the Small Things: Efficiencies for Cloud Hardware
- Cloud Business Solutions, Social Media, and Platform Systems of Engagement Market Shares, Strategies, and Forecasts, Worldwide, 2013 to 2019
- Google Submits Concessions to EC; Gets Sued in the UK
- Global Mobile Security (mSecurity) Market 2013-2018
- RightScale Supports Windows Azure Infrastructure Services General Availability
- Cloud People: A Who's Who of Cloud Computing
- Enterasys Spotlights SDN's Impact on Traditional Networking in Upcoming Webinar
- RetailMeNot Shoppers Trend Report: While Over 8 in 10 U.S. Residents Cite Affordability as Their Top Vacation Priority, a Majority (58%) Could Waste Hundreds of Dollars by Booking Travel a la Carte
- NASA's Twitter Account Wins Back-To-Back Shorty Awards
- ChannelAdvisor Participates in Upcoming Retail Industry Conferences RBTE and Retail Week Live
- Basho Announces Open Source Riak CS and General Availability of Riak CS Enterprise v1.3
- Google Compute enters the IaaS market
- How to Protect Your Facebook Account Before Graph Search is Public
- Google Says Motorola’s Upcoming Phones Don’t ‘Wow’ Them
- Why Cloud Computing Skills Will Be Required for IT Workers
- GoBank Announces Timing of General Availability and National Distribution Relationships at FinovateSpring
- MicroStrategy Announces General Availability of MicroStrategy 9.3.1
- Where Are RIA Technologies Headed in 2008?
- Cloud People: A Who's Who of Cloud Computing
- Dolphin Announces Open API With Over 50 Add-ons Including Dropbox and Wikipedia
- ManageWP Powers Over 100,000 WordPress Sites Within Three Months of Launch
- SEO/SEM Tips & Tricks: How and When Should You Submit Your Website to Google?
- Google Version 2.0: Googzilla - The Calculating Predator
- Google's Competitive Advantage: It Leverages "The Power of Free"
- Cloud Expo 2011 East To Attract 10,000 Delegates and 200 Exhibitors
- Google Space Launches at Heathrow Airport
- AOL To Enhance Video Search Engine by Adding RSS Feeds
- Ulitzer’s Amazing First 30 Days in Public Beta
- The World's Youngest "Google Entrepreneur" Is One Month Old




















