Press Release Source: Palatin Technologies, Inc.
Palatin Technologies and King Pharmaceuticals Report Results of a Clinical Study Evaluating Bremelanotide in Post-Menopausal Female Sexual Dysfunction Patients
Thursday August 3, 7:30 am ET
CRANBURY, N.J. and BRISTOL, Tenn., Aug. 3 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (Amex: PTN - News) and King Pharmaceuticals, Inc. (NYSE: KG - News) announced today results of Part 2 of a Phase IIa pilot study evaluating the effects of bremelanotide in post-menopausal women diagnosed with female sexual arousal disorder (FSAD). Results showed that on a 14-item questionnaire, 73 percent of the women reported an increased level of genital arousal while on bremelanotide compared with 23 percent of women on placebo. Also, 46 percent of women on bremelanotide reported an increased level of sexual desire while only 19 percent of women responded similarly after placebo treatment. Additionally, subjects receiving bremelanotide reported a higher incidence of engaging in sexual activity compared to placebo. The current study follows a similarly designed clinical study conducted with pre-menopausal patients with FSAD, the results of which were recently published in the July 2006 issue of The Journal of Sexual Medicine.
"The results of this study in post-menopausal women corroborate the previous results reported in pre-menopausal women and supports the further advancement of bremelanotide for the treatment of FSAD," said Trevor Hallam, Ph.D., Executive Vice President, Research & Development of Palatin Technologies.
Twenty-six women with a diagnosis of FSAD were enrolled at two investigational sites in this double-blind, randomized, placebo-controlled, single dose, cross-over clinical study. All subjects enrolled in this clinical study were evaluated by an experienced clinical psychologist and were confirmed to have a diagnosis of FSAD. Subjects were administered a 20 mg dose (2 x 10 mg) of intranasal bremelanotide or placebo spray in a randomized manner and were monitored and evaluated for three hours post-dose before being discharged from the clinic. All subjects completed a Treatment Satisfaction Index questionnaire at 24-hours post-dose as a means of measuring their levels of sexual desire, genital arousal and, if applicable, satisfaction with sexual activity. Adverse events reported include nausea, headache and nasal congestion and were comparable to adverse events reported for other clinical studies evaluating this dose.
"The data strongly favor and support the companies' development program for bremelanotide," states Dr. Michael A. Perelman, Co-Director of the Human Sexuality Program at Weill Medical College of Cornell University, New York. "I enthusiastically await data from larger clinical trials which are underway."
Palatin Technologies and King Pharmaceuticals plan to more fully present information regarding the results of this study at a future conference. The companies are currently enrolling subjects in a 100 patient, Phase IIb at-home clinical trial in pre-menopausal FSAD patients at approximately 20 clinical sites throughout the United States.
AI
