MOUNTAIN VIEW, Calif., Sept. 1, 2011 /PRNewswire/ — VIVUS,
VVUS) 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 AvanafilAvanafil 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,