Benzinga

España
Italia
대한민국
日本
Français
Benzinga Edge
Benzinga Research
Benzinga Pro

  • Get Benzinga Pro
  • Data & APIs
  • Events
  • Premarket
  • Advertise
Contribute
España
Italia
대한민국
日本
Français

Benzinga

  • Premium Services
  • Financial News
    Latest
    Earnings
    Guidance
    Dividends
    M&A
    Buybacks
    Interviews
    Management
    Offerings
    IPOs
    Insider Trades
    Biotech/FDA
    Politics
    Healthcare
    Small-Cap
  • Markets
    Pre-Market
    After Hours
    Movers
    ETFs
    Options
    Cryptocurrency
    Commodities
    Bonds
    Futures
    Mining
    Real Estate
    Volatility
  • Ratings
    Analyst Color
    Downgrades
    Upgrades
    Initiations
    Price Target
  • Investing Ideas
    Trade Ideas
    Long Ideas
    Short Ideas
    Technicals
    Analyst Ratings
    Analyst Color
    Latest Rumors
    Whisper Index
    Stock of the Day
    Best Stocks & ETFs
    Best Penny Stocks
    Best S&P 500 ETFs
    Best Swing Trade Stocks
    Best Blue Chip Stocks
    Best High-Volume Penny Stocks
    Best Small Cap ETFs
    Best Stocks to Day Trade
    Best REITs
  • Money
    Investing
    Cryptocurrency
    Mortgage
    Insurance
    Yield
    Personal Finance
    Forex
    Startup Investing
    Real Estate Investing
    Prop Trading
    Credit Cards
    Stock Brokers
Research
My Stocks
Tools
Free Benzinga Pro Trial
Calendars
Analyst Ratings Calendar
Conference Call Calendar
Dividend Calendar
Earnings Calendar
Economic Calendar
FDA Calendar
Guidance Calendar
IPO Calendar
M&A Calendar
Unusual Options Activity Calendar
SPAC Calendar
Stock Split Calendar
Trade Ideas
Stock Reports
Insider Trades
Trade Idea Feed
Analyst Ratings
Unusual Options Activity
Heatmaps
Free Newsletter
Government Trades
Perfect Stock Portfolio
Easy Income Portfolio
Short Interest
Most Shorted
Largest Increase
Largest Decrease
Calculators
Margin Calculator
Forex Profit Calculator
100x Options Profit Calculator
Screeners
Stock Screener
Top Momentum Stocks
Top Quality Stocks
Top Value Stocks
Top Growth Stocks
Compare Best Stocks
Best Momentum Stocks
Best Quality Stocks
Best Value Stocks
Best Growth Stocks
Connect With Us
facebookinstagramlinkedintwitteryoutubeblueskymastodon
About Benzinga
  • About Us
  • Careers
  • Advertise
  • Contact Us
Market Resources
  • Advanced Stock Screener Tools
  • Options Trading Chain Analysis
  • Comprehensive Earnings Calendar
  • Dividend Investor Calendar and Alerts
  • Economic Calendar and Market Events
  • IPO Calendar and New Listings
  • Market Outlook and Analysis
  • Wall Street Analyst Ratings and Targets
Trading Tools & Education
  • Benzinga Pro Trading Platform
  • Options Trading Strategies and News
  • Stock Market Trading Ideas and Analysis
  • Technical Analysis Charts and Indicators
  • Fundamental Analysis and Valuation
  • Day Trading Guides and Strategies
  • Live Investor Events
  • Pre-market Stock Analysis and News
  • Cryptocurrency Market Analysis and News
Ring the Bell

A newsletter built for market enthusiasts by market enthusiasts. Top stories, top movers, and trade ideas delivered to your inbox every weekday before and after the market closes.

  • Terms & Conditions
  • Do Not Sell My Personal Data/Privacy Policy
  • Disclaimer
  • Service Status
  • Sitemap
© 2026 Benzinga | All Rights Reserved
August 27, 2018 7:30 AM 5 min read

VIVUS Reports Data Supporting the Cardiovascular Safety of Qsymia®

by Globe Newswire
Follow
FlipboardIcon version of the Flipboard logo

-Retrospective analysis presented at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management-

CAMPBELL, Calif., Aug. 27, 2018 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company"))), a biopharmaceutical company, has reported encouraging data from a retrospective analysis evaluating the cardiovascular safety of Qsymia® (phentermine and topiramate extended-release) capsules CIV.  Results show that the risk of major adverse cardiovascular events (MACE) trended lower in patients taking Qsymia compared with similar patients who were not taking Qsymia.  The results were presented yesterday in a poster at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, which took place in Prague, Czech Republic, August 22-26.

"The results of this retrospective analysis add to the body of data demonstrating that Qsymia does not increase the risk of MACE," said John Amos, Chief Executive Officer at VIVUS.  "We continue to believe that Qsymia provides patients with significant benefits as a platform for managing body mass index, and our ongoing dialogue with the U.S. Food and Drug Administration includes a label modification request to allow for the safe and effective short-term utilization of Qsymia while significantly reducing or eliminating the requirement for conducting a cardiovascular outcomes study."

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; 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.



Market News and Data brought to you by Benzinga APIs

© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

To add Benzinga News as your preferred source on Google, click here.


Posted In:
Press Releases
Beat the Market With Our Free Pre-Market Newsletter
Enter your email to get Benzinga's ultimate morning update: The PreMarket Activity Newsletter

Results of the study were presented in a poster titled "Cardiovascular Safety of Phentermine and Topiramate in a United States Claims Database," (Abstract 983/118). The study was a retrospective cohort analysis conducted in MarketScan Commercial Claims and Medicare Supplemental data. The study evaluated MACE rates during periods of exposure to Qsymia, generic phentermine and topiramate combinations (PHEN/TPM) and phentermine (PHEN) or topiramate (TPM) alone, and compared each of these to MACE rates during unexposed periods in former users of these drugs. MACE was defined as a composite of hospitalization for acute myocardial infarction (AMI), stroke, or in-hospital cardiovascular-related death as determined via discharge status and ICD-9-CM diagnoses.

Propensity scores were calculated to adjust for differences in cardiovascular risk factors among the cohorts. Propensity score-adjusted analyses showed that MACE risk trended lower with current Qsymia and PHEN/TPM use compared with the unexposed cohort. Compared to the unexposed cohort, MACE risk was also lower with current PHEN use and higher with current TPM use. The study authors note that the small number of events that occurred during exposure to Qsymia and PHEN/TPM produced considerable statistical uncertainty in the analysis of these cohorts.

About Qsymia
Qsymia is approved in the United States 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.

About VIVUS
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs.  For more information about the Company, please visit www.vivus.com.

Forward-Looking Statements
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 timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration, or FDA; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to our ability to work with FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial, or CVOT; risks and uncertainties related to the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy, or REMS, requirements; risks and uncertainties related to the fact that we may be required to provide further analysis of previously submitted clinical trial data; and risks and uncertainties related to our dialog with the European Medicines Agency, or EMA, relating to real world safety data for Qsymia and the resubmission of the marketing authorization application, and the assessment by the EMA of the marketing authorization application and the real world safety data. 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' Form 10-K for the year ended December 31, 2017 as filed on March 14, 2018, and as amended by the Form 10-K/A filed on April 26, 2018, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

VIVUS, Inc.Investor Relations: Lazar Partners
Mark OkiDavid Carey
Chief Financial OfficerManaging Director
[email protected][email protected]
650-934-5200212-867-1768

Comments
Loading...