MOUNTAIN VIEW, Calif., Nov. 16 /PRNewswire-FirstCall/ -- VIVUS, Inc. today announced the completion of a Phase 2 clinical study of Testosterone MDTS(R) (Metered Dose Transdermal Spray). Testosterone MDTS is being developed for the treatment of Hypoactive Sexual Desire Disorder (HSDD), a disorder that affects approximately 25 percent of the adult female population.
The six-month, multi-center, double-blind, placebo controlled trial enrolled 260 female patients with HSDD. Patients used the Testosterone MDTS delivery system to self-administer either testosterone or placebo. The trial was conducted in Australia by Acrux Limited , the licensor of the MDTS system to VIVUS. Results from the study will be announced in the first quarter of 2005.
"Based on market research, we believe the MDTS system will be preferred by women due to its easy and discrete way of applying testosterone," stated Leland Wilson, President and CEO of VIVUS. "Additionally, the MDTS technology is non-messy and provides an invisible application that dries in seconds."
MDTS System
MDTS(R) (Metered Dose Transdermal Spray) is a patented new-generation transdermal delivery system. MDTS features a small, discrete, hand-held applicator that delivers a pre-set dose of a proprietary formulation of testosterone to the skin where it is released into the blood stream on a sustained basis over 24 hours. The MDTS spray is fast drying, non-irritating and invisible after application.
About Acrux
Acrux Limited's group of companies is engaged in the development and commercialization of a range of patented, patient-preferred healthcare products for global markets. Acrux has completed fourteen human clinical trials with six different drugs using its proprietary drug delivery technology, comprising ACROSS(R) penetration enhancers, Metered Dose Transdermal System (MDTS(R)) applicators for transdermal administration, and Patchless Patch(R) delivery method. Acrux's portfolio includes treatments of hormonal deficiencies, pain, central nervous system disorders and urinary incontinence, as well as a contraceptive. Acrux has licensed USA rights to its two lead products, Estradiol MDTS(R) and Testosterone MDTS(R), to VIVUS and AUS/NZ distribution rights for Testosterone MDTS(R) to CSL Limited. Acrux has also licensed its technology for commercial development to Eli Lilly for veterinary healthcare products, and to Connetics Australia, a subsidiary of the US Company Connetics, for anti-psoriatics and local anaesthetics. For more information please visit the Company's web site at http://www.acrux.com.au/.
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 products in late stage clinical development. For women, VIVUS has initiated its Phase 3 program with ALISTA(TM) for sexual arousal disorder, and anticipates entering Phase 3 studies with testosterone and estradiol for the treatment of sexual desire disorder and alleviation of menopausal symptoms via its novel Metered Dose Transdermal Spray (MDTS(R)) delivery system. 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 US for the treatment of erectile dysfunction. For more information on clinical trials, products and corporate goals, 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, 2003 and periodic reports filed with the Securities and Exchange Commission.
CONTACT: Christina Weisgerber of VIVUS Inc., +1-650-934-5240; or Nina Ferrari, +1-415-318-4286, or Marie Villalba, +1-415-318-4254, both of Fleishman Hillard, for VIVUS, Inc.
VIVUS, Inc.