VIVUS Inc. has announced that clinical data from a Phase 2 study showed treatment with the Company's Testosterone MDTS, an investigational transdermal testosterone spray, significantly increased the number of satisfactory sexual events in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD).

The 28-week, double-blind, randomized, placebo controlled, dose-ranging study consisted of 261 premenopausal women with low serum testosterone and low libido that caused distress. The primary endpoint of the study was the number of satisfactory sexual events reported by women over a 4-week period at week 16.

The study was conducted at 6 sites across Australia by Acrux Limited, under an Investigational New Drug (IND) Application on file with the United States Food and Drug Administration (FDA).

Study results showed a statistically significant (p<0.05) increase in the number of satisfactory sexual events at week 16 for the second highest dose of testosterone MDTS compared to placebo. A positive trend was observed in all treatment groups from week four compared with baseline. In the most effective treatment group, the number of satisfactory sexual events more than doubled at week 16 compared with baseline. No serious adverse events resulting in discontinuation of the study occurred in any subject receiving testosterone MDTS. The most common side effect was a mild increase in hair growth, resulting in only two patients withdrawing from the study, both in the highest dose group. The incidence of skin irritation was very low and reported as mild, the company release said.

"Earlier studies have demonstrated the efficacy of transdermal testosterone delivery for the treatment of naturally and surgically menopausal women. This new study supports the findings of our earlier study that premenopausal women with low libido can also enjoy an increase in satisfactory sexual events following treatment with transdermal testosterone," said Susan Davis
Professor of Women's Health at Monash University and Principal Investigator.

"Testosterone MDTS is an important component of our entire development pipeline, which includes Alista for the treatment of Female Sexual Arousal Disorder and Evamist for the treatment of menopausal symptoms, both currently in Phase 3 development," commented Leland Wilson, president and CEO for VIVUS.

Testosterone (Metered Dose Transdermal Spray) is a patented new-generation transdermal spray. 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, the company release says.

VIVUS Inc. is a pioneer in the research and development of proprietary products to restore sexual function for men and women.