MOUNTAIN VIEW, Calif., May 14, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS), a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today announced the following scientific presentations:
|20th European Congress on Obesity (ECO), Arena and Convention Centre Liverpool (UK)|
|Date / Time / Details|
|Poster Number: T5:P.106|
|Track Number: 5|
|Session Date: Monday, May 13, 2013|
|Presentation Time: 1315 – 1445 hrs|
|Does a History of Depression and/or Antidepressant Use Affect the Weight Loss Efficacy of Phentermine and Topiramate Extended-Release?|
|Patrick M. O'Neil, PhDa; Timothy Church, MDb; Barbara Troupin, MD, MBAc|
|aMedical University of South Carolina, Charleston, SC|
|bPennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA|
|cVIVUS, Inc., Mountain View, CA|
|Date / Time / Details|
|Presentation Date: Wednesday, May 15, 2013|
|Presentation Location: Hall 7|
|Session Time: 0945 – 1115 hrs|
|Presentation Time: 1000 – 1015 hrs|
|Weight Loss and Improvements in Hypertension Status Associated With Phentermine and Topiramate Extended-Release Treatment in Obese and Overweight Adults|
|Nick Finer, MBBS, BSc, FRCPa Jens Jordan, MDb Roman V. Dvorak, MD, PhDc|
|aInstitute for Cardiovascular Science, University College London, UK|
|bInstitute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany|
|cVIVUS, Inc., Mountain View, CA|
Qsymia® (phentermine and topiramate extended-release) capsules CIV 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.
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 and sexual health. 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 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; 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; risks and uncertainties related to whether the EC will approve the SPEDRA MAA on the anticipated timing, or at all; risks and uncertainties related to the completion of our avanafil partnering discussions on acceptable terms and on a timely basis; and risks and uncertainties related to the launch and commercialization of SPEDRA in the EU. 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, as amended by the Form 10-K/A filed on April 30, 2013, 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 of proxies from VIVUS stockholders. INVESTORS AND STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ ANY SUCH PROXY STATEMENT AND ACCOMPANYING PROXY CARD AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION. Information 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, Amendment No. 1 to VIVUS's Annual Report on Form 10-K/A, filed with the SEC on April 30, 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 www.sec.gov. Copies will also be available at no charge at the Investor Relations section of VIVUS's corporate website at www.vivus.com.