"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."
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(R), 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(R) (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.