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Female Hormonal Deficiencies/Abnormalities

October 22, 2007

Palatin issued positive results from a phase II trial of bremelanotide for the treatment of female sexual arousal disorder. This double-blinded, placebo-controlled trial enrolled 163 pre- and postmenopausal women. The subjects were followed for one month to determine their baseline level of sexual dysfunction and were then randomized to receive intranasal doses of either placebo or bremelanotide (10 mg). The subjects were assessed over a two month period for changes in sexual function using the Female Sexual Encounter Profile (FSEP), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Score (FSDS). The postmenopausal women showed statistically significant improvements in the endpoints when compared to baseline and placebo, and overall satisfaction at one and two months. The pre-menopausal women treated with bremelanotide showed statistically significant improvements in the endpoints when compared to baseline and overall satisfaction at one and two months. However, while a positive trend toward improvement was seen in this group when compared to placebo, the differences were not statistically significant. Based on the results, Palatin plans to move forward with the development of bremelanotide.