QsymiaTreatment for Obesity
Update: Qsymia (phentermine/topiramate) Now FDA Approved - July 17, 2012
VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity
MOUNTAIN VIEW, Calif., March 26 /PRNewswire-FirstCall/ -- VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is tentatively scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on July 15, 2010. VIVUS submitted its NDA on December 28, 2009 seeking approval to market Qnexa in the United States; on March 1, 2010, the FDA accepted the NDA filing for review. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.
"Review by the Advisory Committee represents a critical milestone for Qnexa and for VIVUS. We believe Qnexa, if approved, could become a treatment option for obese patients," stated Leland Wilson, chief executive officer of VIVUS. "We look forward to discussing the efficacy and safety data of Qnexa with the members of the Endocrinologic and Metabolic Drugs Advisory Committee."
The FDA will publish the final meeting date in the Federal Register http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm .
Changes to the Advisory Committee meetings calendars may also be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm .
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. The company's lead product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of October 28, 2010. 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 potentially best-in-class PDE5 inhibitor for the treatment of erectile dysfunction, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. 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.
CONTACT: VIVUS, Inc., Timothy E. Morris, Chief Financial Officer, +1-650-934-5200, or Investor Relations: The Trout Group, Brian Korb, +1-646-378-2923; or Media Relations: Pure Communications, Inc., Dan Budwick, +1-973-271-6085
Web Site: http://www.vivus.com/
Posted: March 2010
- FDA Approves Weight-Management Drug Qsymia - July 17, 2012
- Vivus Receives Notification of Qnexa PDUFA Date Extension - April 10, 2012
- FDA Advisory Committee Recommends Approval of Qnexa - February 23, 2012
- VIVUS Provides Qnexa Regulatory Update - January 9, 2012
- VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity - December 27, 2011
- FDA Accepts New Drug Application Filing for Qnexa - November 3, 2011
- VIVUS Resubmits Qnexa NDA to the FDA - October 17, 2011
- VIVUS Provides Regulatory Update on Qnexa NDA - January 21, 2011
- VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA - December 14, 2010
- FDA Issues Complete Response Letter to Vivus Regarding New Drug Application for Qnexa - October 29, 2010
- Vivus Comments on FDA Advisory Committee Panel Meeting on Qnexa (phentermine/topiramate) Controlled Release Capsules for the Treatment of Obesity - July 16, 2010
- VIVUS Announces FDA Acceptance of Qnexa New Drug Application for Treatment of Obesity - March 2, 2010
- Vivus Submits Qnexa New Drug Application to the FDA for the Treatment of Obesity - December 29, 2009