VIVUS MEETS WITH FDA FOR THE DEVELOPMENT OF TESTOSTERONE FOR HSDD
VIVUS has reported on its recent meeting with the FDA regarding Testosterone
MDTS (Metered Dose Transdermal Spray) for the treatment of Hypoactive Sexual
Desire Disorder (HSDD). The purpose of the meeting was to share results from
the Phase II clinical study with the FDA and to discuss the Phase III study
requirements for obtaining approval for this indication.
Based on the meeting and the discussions with the FDA, over the next several months VIVUS intends to complete the design of the Phase III safety and efficacy studies for Testosterone MDTS to treat HSDD.
Earlier in the year, VIVUS announced the Phase II results from a double-blind, randomized, placebo-controlled, dose-ranging study consisting of 261 premenopausal women, 35-45 years old, with low serum testosterone and low libido. The study found that patients treated with the Testosterone MDTS had an increase in libido level, as compared to baseline and placebo.