Navigation Links
VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
Date:12/14/2010

MOUNTAIN VIEW, Calif., Dec. 14, 2010 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the company, as part of its continuing effort to secure regulatory approval for QNEXA® in the U.S., submitted a briefing document to the Food and Drug Administration (FDA) designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, 2010.  The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the second half of January 2011 to discuss the content of the proposed resubmission.

VIVUS is pursuing regulatory approval to market QNEXA (phentermine/topiramate) Controlled Release Capsules in the U.S. for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

"Submission of our briefing document and confirmation of our meeting with the FDA indicate the continued progress VIVUS is making in seeking U.S. approval of QNEXA® for the treatment of obesity," said Leland Wilson, chief executive officer of VIVUS. "We are confident in the data analyses we have compiled in the briefing document, and we look forward to our meeting with the FDA."

About QNEXA Controlled Release Capsules

QNEXA [kyoo-nek-suh] is an investigational drug being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which together decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program.

About Obesity

Obesity is a chronic condition defined by having excess body fat. Obesity significantly increases the risk of developing many different diseases and health conditions, including type 2 diabetes, hypertension, metabolic syndrome, cardiovascular disease, some cancers and osteoarthritis. According to a report in The Lancet in 2009, morbid obesity shortens life expectancy by approximately 10 years, and moderate obesity shortens it by approximately 3 years.

Approximately one-third of American adults (more than 72 million people) are obese, and many more are overweight with co-morbidities. Beyond its impact on health, obesity accounts for 9.1% of US annual health care spending – nearly $150 billion.

About VIVUS

VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US regulators. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. 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," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. 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, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.


'/>"/>
SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. VIVUS to Present at Two Upcoming Investor Conferences
2. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
3. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
4. VIVUS Announces Sale of MUSE Assets to Meda
5. VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity
6. VIVUS to Host Conference Call and Webcast Discussion of Avanafil Phase 3 Results
7. VIVUS to Present at Lazard Capital Markets Healthcare Conference
8. VIVUS Announces Promotion of Peter Tam to President
9. Data on VIVUS Qnexa to be Featured at European Association for the Study of Diabetes Annual Meeting
10. VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction
11. Results From Phase 3 EQUATE Trial of VIVUS Qnexa Highlighted at European Congress on Obesity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/28/2017)... -- The global  pulse oximeters market  is expected to reach USD ... Inc. The pulse oximeters market is anticipated to witness significant growth during the ... such as chronic obstructive pulmonary disease (COPD), sleep apnea, cardiac arrhythmia, and ischemic ... ... Grand View Research Logo ...
(Date:2/28/2017)... -- Nordic Nanovector ASA (OSE: NANO) announces its results ... the results by the company,s senior management team will take place ... - details below. ... 2016 was a very successful year for Nordic Nanovector. We achieved ... with our preclinical candidates and build the foundation of R&D innovation ...
(Date:2/27/2017)... -- Halyard Health, Inc. (NYSE: HYH ) today ... 2017 outlook and related key planning assumptions. Executive Summary ... 2 percent increase compared to the prior year. ... million compared to net income of $15 million in the ... $24 million compared to adjusted net income of $27 million ...
Breaking Medicine Technology:
(Date:2/28/2017)... ... February 28, 2017 , ... The role of females ... from military to civilian life. Body image dissatisfaction is largely unexamined among female ... and greater occurrence of chronic mental health conditions than female civilians. Female veterans ...
(Date:2/27/2017)... ... February 27, 2017 , ... Robert E. Burke, MD, PhD, had a ... impoverished upbringing and life experiences could have led him down a much different path. ... Tales of Parenting, Perseverance and Pediatrics,” Dr. Burke shares a personal account of the ...
(Date:2/27/2017)... ... February 27, 2017 , ... Orange County dentist, ... inflammatory gum condition that occurs when the bacteria in plaque infect the gums and ... as a scaling and root planing or SRP, and can include surgical therapies if ...
(Date:2/27/2017)... ... February 27, 2017 , ... ... alcohol treatment programs in British Columbia, Canada, at https://www.sunshinecoasthealthcentre.ca/ , is proud ... The new hire, Mackenzie Alsager, showcases the Centre's commitment to innovation in drug ...
(Date:2/26/2017)... ... 2017 , ... Today, A' Design Awards & Competition has ... Design Awards. , The 7th A' Social Design Award is open for ... with realized projects and conceptual works. , The first phase of the International ...
Breaking Medicine News(10 mins):