VIVUS Announces Patient Enrollment in At-Home Study with TA-1790 in Men with Erectile Dysfunction.
Business Editors/Health/Medical Writers
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--July 10, 2003
VIVUS, Inc. (Nasdaq:VVUS) today announced that it has begun enrolling patients in a clinical trial of TA-1790 in men with erectile dysfunction (ED). One of the study's primary goals is to confirm data demonstrating that TA-1790 produces a maximum increase in penile rigidity sooner than that seen with sildenafil, the active ingredient in Viagra(R).
"Our development program for TA-1790 is progressing on schedule with initiation of this study," commented Dr. John Dietrich, Vice President, Research and Development at VIVUS. "One of the critical attributes of a treatment for ED is a rapid onset of action, as this provides the patient and his partner opportunity for a greater degree of spontaneity. The data we have generated to date suggests that TA-1790 may be the most rapidly acting PDE5 inhibitor and could provide a significant advantage in comparison with other PDE5 inhibitors for the treatment of ED."
This at-home study is a double-blind, randomized, crossover design, to evaluate the safety and efficacy of TA-1790, a fast-acting, highly-selective, potent, orally-active phosphodiesterase type 5 (PDE5) inhibitor. In addition to measuring erectile function, the trial will provide further information regarding the onset of action of the PDE5 inhibitor. In a previous study, twice as many subjects treated with TA-1790 demonstrated greater than 60% penile rigidity compared to Viagra(R) at the earliest time point tested. This early activity correlates with the fast oral absorption and short time to maximum blood concentration (Tmax) observed in recent studies.
VIVUS, Inc. is a pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, with a focus on sexual dysfunction. Current development programs target Female Sexual Dysfunction (FSD), Erectile Dysfunction (ED) and Premature Ejaculation (PE). VIVUS developed and markets in the U.S. MUSE(R) (alprostadil) and ACTIS(R), two innovations in the treatment of erectile dysfunction, and has partnered with Meda AB (Stockholm:MEDAa.ST) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Labs (TSE:PLB) to market and distribute MUSE. For more information, please visit the Company's Web site at: www.vivus.com.
This news release contains forward-looking statements about the expected use of funds and the potential development and commercialization of products in treating male sexual dysfunction that are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to be materially different from any future results expressed or implied by such forward-looking statements. As with any pharmaceutical under development, there are significant risks and uncertainties in development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this news release will be successful or that any product will receive regulatory approval for any indication. Further, even if the Company were to receive regulatory approval for a product, there could be no assurance that such a product would prove to be commercially successful. Please see the Company's filings with the Securities and Exchange Commission, including, without limitation, the Company's Annual Report on Form 10-K for the year ended December 31, 2002, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2003, which identify these and other risks and uncertainties that may cause actual results or events to differ materially from those described in this news release.