Positive Results From Avanafil Phase 3 Study in Diabetics Presented at the 47th EASD Annual Meeting

Update: Stendra (avanafil) Now FDA Approved - April 27, 2012

Diabetic Patients Treated with Avanafil Experience Significant Improvement in Erectile Function

MOUNTAIN VIEW, Calif., Sept. 13, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today presented positive results from the avanafil phase 3 study in diabetics.  In the REVIVE-Diabetes study (TA-302), male diabetics receiving avanafil had significant improvement in erectile function.  Dr. Irwin Goldstein, Director of Sexual Medicine at Alvarado Hospital, San Diego, CA, presented the results of the study during the poster session at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal.  Results of the study have been previously reported, but this was the first public European presentation of avanafil safety and efficacy data in diabetic patients.  

The study included 390 patients with type 1 and type 2 diabetes treated over 12 weeks with avanafil 100mg, 200mg, or placebo.  Diabetics are disproportionately affected by erectile dysfunction (ED), which can worsen with increased duration of disease, and these patients are often considered less responsive to therapy.

This study population consisted of men with an average age of 58 years and a mean duration of diabetes of eleven years and ED of five to six years.  The majority were type 2 diabetics, with approximately 10% having type 1 diabetes.  Avanafil was associated with significant improvements in erectile function relative to placebo (calculated as least-squares (LS) mean change from baseline for all of the co-primary endpoints (P< 0.0001)).  Subgroup analyses demonstrated that improvements in the percentage of successful intercourse attempts with avanafil 100 mg and avanafil 200 mg were observed regardless of diabetes classification (type 1 or 2), duration of diabetes, or baseline ED severity (P<0.05).  Successful intercourse was achieved in some subjects in 15 minutes or less after dosing with avanafil.  Some subjects had successful intercourse more than six 6 hours after dosing.  The most common adverse events in the avanafil treatment groups were headache, nasopharyngitis, flushing, and sinus congestion.

A copy of the poster titled, "Treatment of Erectile Dysfunction in Men With Diabetes: Results of a Phase 3, Multicentre, Randomized, Controlled Trial of Avanafil" is available on our website at www.vivus.com.  

About Avanafil for Erectile Dysfunction

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.

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," "estimate," "expect," "forecast" and "intend," among others.  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, the timing and substance of our response to the FDA's requests from the QNEXA End-of-Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA's QNEXA CRL; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy; the FDA's interpretation of and agreement with the information VIVUS submitted and may submit relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study, or OB-305; the FDA's requests, if any, to conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; the review and questions from the EMA and CHMP on the QNEXA MAA; substantial competition; the impact on future sales based on specific indication and contraindications contained in the label and the extent of the Risk Evaluation and Mitigation Strategies program; uncertainties of litigation and intellectual property and patent protection; reliance on sole-source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products; risks related to the failure to obtain FDA or foreign authority clearances or approval; noncompliance with FDA or foreign regulations; and our dependence on the performance of our collaborative partners.  As with any pharmaceutical in development, there are significant risks in the development, regulatory approval, and commercialization of new products.  There are no guarantees that our response to the FDA's CRL on QNEXA or the results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy and subsequent meetings and communications will be sufficient to satisfy the FDA's safety concerns, that the FDA will not require us to conduct any additional  prospective studies or retrospective observational studies, or that any product will receive regulatory approval for any indication or prove to be commercially successful.  There is no guarantee that the FDA will approve our NDA for avanafil as a treatment of ED.  VIVUS does not undertake an obligation to update or revise any forward-looking statements.  Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ending December 31, 2010, and periodic reports filed with the Securities and Exchange Commission.

CONTACT:

 

 

 

 
 

VIVUS, Inc.

 Investor Relations:

The Trout Group

 

Timothy E. Morris


 

Brian Korb

 

Chief Financial Officer


 

bkorb@tro u tgroup.com

 

650-934-5200


 

646-378-2923

 
     


 

SOURCE VIVUS, Inc.

Web Site: http://www.vivus.com

Posted: September 2011

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