Erectile Dysfunction - Completion of Twice Daily Dosing Study with Avanafil

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 05 May 2005 - 11:00 PST

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VIVUS, Inc today announced results from a clinical trial designed to evaluate the feasibility of twice-a-day dosing with avanafil, its investigational oral phosphodiesterase type 5 (PDE5) inhibitor being developed for the treatment of erectile dysfunction. This open-label, pharmacokinetic study compared blood levels of avanafil, in healthy volunteer subjects after taking a single dose of avanafil with blood levels after taking avanafil twice daily (every 12 hours) for seven days. Results revealed no significant plasma accumulation of avanafil after the twice-a-day treatment regimen when compared to the single dose, indicating the drug was quickly removed from the blood stream. A total of fifteen subjects were enrolled in the study, with thirteen subjects included in the final evaluation.

"These results are encouraging and support our development strategy that avanafil may have a different profile than existing PDE5 inhibitors; however, further clinical testing will be needed to define the ultimate use of avanafil," commented Dr. John Dietrich, Vice President, Research and Development. "This study corroborates earlier studies that demonstrated a short plasma half-life of avanafil of 60-90 minutes. This rapid disappearance and lack of accumulation in the blood suggests the possibility of twice-a-day dosing with avanafil. Currently, the maximum recommended dosing frequency of approved PDE5 inhibitors is once a day."

About VIVUS

VIVUS, Inc. is a pioneer in the research and development of proprietary products to restore sexual function for men and women. VIVUS' current product pipeline includes four investigational products in late stage clinical development. For women, VIVUS has initiated its Phase 3 programs with ALISTA(TM) (topical alprostadil) for female sexual arousal disorder, and Evamist(TM) (estradiol MDTS) for the alleviation of menopausal symptoms. Testosterone MDTS(R) for the treatment of hypoactive sexual desire disorder has completed Phase 2 development. The MDTS system is a patented new- generation, transdermal drug delivery technology that delivers drugs through the skin. For men, VIVUS is developing avanafil for erectile dysfunction, which is currently in a Phase 2 program. VIVUS currently markets MUSE(R) (alprostadil) suppository in the U.S. and internationally through distributors for the treatment of erectile dysfunction. For more information on clinical trials and products, please visit the Company's web site at http://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," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. 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, substantial competition; uncertainties of patent protection and litigation; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2004 and periodic reports filed with the Securities and Exchange Commission.

For more information:
VIVUS, Inc.
Christina Weisgerber
650-934-5240

VIVUS, Inc.
http://www.vivus.com

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