MOUNTAIN VIEW, Calif., Sept. 1, 2011 /PRNewswire/ -- VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for its investigational drug candidate, avanafil, for the treatment of erectile dysfunction (ED). The target date for the FDA to complete its review of the avanafil NDA is April 29, 2012. In previously announced results from the pivotal phase 3 trials, patients treated with avanafil achieved significant improvement in erectile function compared to placebo. The avanafil development program included over 1,350 patients and avanafil was shown to be well tolerated and effective in treating patients with general ED and diabetics with ED. The long-term safety study also confirmed the results observed in the phase 3 studies.
"We are pleased with FDA's acceptance of our NDA. If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED," stated Peter Y. Tam, president of VIVUS.
About Avanafil
Avanafil is an investigational oral medication being developed for the treatment of erectile dysfunction. Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor licensed from Mitsubishi Tanabe Pharma Corporation. VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian Pacific Rim countries.
About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational 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 and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial QNEXA NDA on October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of obstructive sleep apnea and type 2 diabetes . In the area of sexual health, VIVUS completed phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, and avanafil is currently under review by the FDA. For more information about the company, please visit www.vivus.com.
No comments:
Post a Comment