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Vivus submits ED drug avanafil in the USA
 
 
  World News | July 01, 2011

Kevin Grogan

Vivus submits ED drug avanafil in the USA

Vivus has filed its impotence drug avanafil with the US Food and Drug Administration.

The New Drug Application is based on a Phase III programme which included over 1,350 patients. Data showed that avanafil, which is licensed from Japan's Mitsubishi Tanabe Pharma Corp, was well tolerated and effective in treating men with erectile dysfunction.

All doses tested - 50mg, 100mg and 200mg - met each of the co-primary efficacy endpoints of the studies, Vivus notes, with the 200mg dosage performing well in terms of erections sufficient for penetration and successful intercourse. Across all the Phase III studies, success in the latter was observed in some avanafil-treated patients as early as 15 minutes after dosing.

Leland Wilson, Vivus chief executive, noted that the drug was well tolerated and had a low dropout rate in all of the trials. If approved, "avanafil could be an attractive treatment alternative for the 30 million men in the USA who suffer from ED", he added.

Mr Wilson concluded by saying that "the unique profile of potentially faster onset and greater selectivity should allow avanafil to effectively compete in the $4 billion worldwide ED market". The latter is currently dominated by Pfizer's Viagra (sildenafil), followed by Eli Lilly's Cialis (tadalafil) and GlaxoSmithKline/Bayer's Levitra (vardenafil).

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VIVUS Submits New Drug Application for Avanafil for the Treatment of Erectile Dysfunction press release

30 Jun 2011

VIVUS announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED)

MOUNTAIN VIEW, CA, USA | June 30, 2011 | VIVUS, Inc. (NASDAQ:VVUS - News) today announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1,350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED.

"This NDA filing is yet another major milestone for VIVUS and the avanafil program. The efficacy was consistent across all patient groups, with success observed in some patients in as early as 15 minutes after dosing. The drug was well tolerated and had a low dropout rate in all of the clinical trials. If approved, avanafil could be an attractive treatment alternative for the 30 million men in the United States who suffer from ED," stated Leland F. Wilson, chief executive officer for VIVUS. "The unique profile of potentially faster onset and greater selectivity should allow avanafil to effectively compete in the $4 billion worldwide ED market. I wish to thank all of the VIVUS employees, investigators, advisors, patients and our development partner, Mitsubishi Tanabe Pharma Corporation, who contributed to the program and made this filing possible."

The NDA includes results from two placebo-controlled, randomized, double-blind, multicenter studies: REVIVE, which included 646 men from the general population with ED, and REVIVE-Diabetes, which included 390 diabetics. Also included are the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies. Previously reported highlights from the avanafil development program include:

All doses tested - 50 mg, 100 mg, and 200 mg - met each of the co-primary efficacy endpoints of the studies

Erections sufficient for penetration (SEP2) were observed in 77% and 63% of avanafil patients at the 200 mg dose, as compared to 54% and 42% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively

Successful intercourse (SEP3) was achieved in 57% and 40% of avanafil patients at the 200 mg dose, as compared to 27% and 20% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively

Significant improvement in erectile function as measured by IIEF-EF domain score was observed for all doses in avanafil-treated patients

Across all the phase 3 studies, successful intercourse (SEP3) was observed in some avanafil-treated patients as early as 15 minutes after dosing

The most common side effects were headache, flushing, nasopharyngitis and nasal congestion

There were no drug-related serious adverse events reported in the studies

About the Avanafil Phase 3 Program

The avanafil phase 3 program consists of three pivotal studies: TA-301 (REVIVE), TA-302 (REVIVE-Diabetes) and TA-303 (REVIVE-RP), as well as a 52-week, open-label, long-term safety study. TA-301, TA-302 and TA-303 were all randomized, double-blind, placebo-controlled phase 3 studies of avanafil in patients with a history of ED for at least six months. Each of the pivotal trials has a similar trial design with patients undergoing a four-week, non-treatment run-in period followed by 12 weeks of treatment. Primary endpoints of the studies are improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF domain score of the International Index of Erectile Function (IIEF). REVIVE-RP was not required for the NDA filing.

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. With the exception of certain Asian Pacific Rim countries, VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction.

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 U.S. 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 type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has completed 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.

SOURCE: VIVUS, Inc.

 
 
 
 
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