Navigation Links
VIVUS Provides Regulatory Update on QNEXA NDA
Date:1/21/2011

MOUNTAIN VIEW, Calif., Jan. 21, 2011 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational drug for the treatment of obesity.  The meeting occurred on January 19th at the FDA's offices in Maryland and was attended by senior members of the FDA and VIVUS' management and consultants.  At this meeting the FDA requested that VIVUS assess the feasibility of analyzing existing healthcare databases to determine the historical incidence of oral cleft in offspring of women treated with topiramate for migraine prophylaxis (100 mg).

Based on discussions at the meeting, VIVUS believes the FDA's additional request stems from two published reports which cited two oral clefts in the UK Epilepsy and Pregnancy Register (Hunt et al., July 2008) and four, including two isolated cleft lips, from the North American AED Pregnancy Registry (Hernandez-Diaz et al., June 2010).  In the QNEXA® studies, which included 15 births from women exposed to QNEXA® or topiramate, there were no reports of any fetal malformations. The timing of the planned resubmission of the QNEXA® NDA will be determined after agreement with the FDA is reached on the feasibility assessment.  VIVUS anticipates continued dialog with the FDA on the planned resubmission of the QNEXA® NDA.

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 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," "planned," "estimated," and "intend," among others.  These forward-looking statements are based on Vivus' current expectations, and actual outcomes 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, the FDA's meeting minutes, the FDA's interpretation of and their agreement with the information Vivus has submitted and plans to submit relating to the teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study, or OB-305; their request, if any, to conduct additional clinical trials or analysis; substantial competition; uncertainties of patent protection and litigation; reliance on sole source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products, and risks related to the failure to obtain FDA clearances or approvals and non-compliance with FDA regulations. As with any pharmaceutical in development, there are significant risks in the development, regulatory approval and commercialization of new products.  There are no guarantees that our response and further submissions will be sufficient to satisfy the FDA's safety concerns, and that the FDA will not require us to conduct any additional studies or analyses 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 statements.  Investors should read the risk factors set forth in the Vivus Form 10-K for the year ending December 31, 2009, and periodic reports filed with the Securities and Exchange Commission. All investors are encouraged to review each presentation in its entirety at www.vivus.com or as filed with the Securities and Exchange Commission at www.sec.gov.  CONTACT:   VIVUS, Inc.Investor Relations:The Trout GroupTimothy E. MorrisBrian KorbChief Financial Officerbkorb@troutgroup.com650-934-5200646-378-2923
'/>"/>

SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. VIVUS to Present at the 2011 JP Morgan Healthcare Conference
2. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
3. VIVUS to Present at Two Upcoming Investor Conferences
4. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
5. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
6. VIVUS Announces Sale of MUSE Assets to Meda
7. VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity
8. VIVUS to Host Conference Call and Webcast Discussion of Avanafil Phase 3 Results
9. VIVUS to Present at Lazard Capital Markets Healthcare Conference
10. VIVUS Announces Promotion of Peter Tam to President
11. Data on VIVUS Qnexa to be Featured at European Association for the Study of Diabetes Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... Indonesia , Jan. 17, 2017  With an annual growth ranging from 6% ... success. CPhI SEA (Jakarta International Expo, March 22-24, 2017) serves the industry ... What,s new at CPhI SEA 2017? Investment Forum ... Distributors, network Richer conference content Enhanced business matchmaking ... ...
(Date:1/18/2017)... , Jan. 18, 2017 Invetech, ... for cell and advanced therapies , has announced ... biopharmaceutical company developing "tumor starvation" treatments for acute ... needs. Under the agreement, Invetech will develop systems ... on Erytech,s proprietary ERYCAPS technology platform, which uses ...
(Date:1/18/2017)... MIAMI , January 18, 2017 ... announced the company plans to publish an online ... the Company,s preliminary sales forecast for 2017. Management ... Company,s trialing ninety-day record sales performance from its ... recently announced entry into the Cannabis sector ...
Breaking Medicine Technology:
(Date:1/17/2017)... ... , ... For breast cancer clinicians and researchers who were unable to attend ... intimate review and analysis of its highlights, a novel half-day, complimentary meeting—the 14th Annual ... on February 4, 2017 in Chicago. Chaired by Kathy S. Albain, MD, FACP, FASCO ...
(Date:1/17/2017)... ... January 17, 2017 , ... SunView Software’s Service Smart Technology has been selected ... , Each year, Pink Elephant recognizes a new product or service developed ... specific business problem or opportunity. The award highlights original innovations that were released in ...
(Date:1/17/2017)... ... January 17, 2017 , ... Metro ... approach to infusing high speed technology into the fabric of an entire community. ... advancement of healthcare and wellness in a yet-to-be-named, health focused campus. Leading this ...
(Date:1/17/2017)... ... 2017 , ... Medic-CE , a Career Step company ... released four new continuing education courses as part of its Code3 CME Virtual ... classroom and meet the requirements of the National Continued Competency Program (NCCP), the ...
(Date:1/17/2017)... ... , ... A prescription medication bottle, pocket knife, luggage and a solar-powered aluminum ... Design Challenge , the Cradle to Cradle Products Innovation Institute has announced. ... to run through early 2018. The challenges are presented by the Institute in partnership ...
Breaking Medicine News(10 mins):