Positive Data From Study Of Pre- And Postmenopausal Women With Female Sexual Arousal Disorder

Sexual Arousal Disorder

Palatin Technologies announced positive results from an at-home Phase 2 trial evaluating bremelanotide for the treatment of female sexual arousal disorder (FSAD). The objective of this exploratory study was to identify potential efficacy endpoints for future studies and to evaluate the safety of intranasal (IN) bremelanotide, relative to placebo and under the conditions of home use, for the treatment of FSAD in pre- and postmenopausal women.

"We are pleased with the overall data from this exploratory trial. The efficacy response was consistent and robust across all domains, particularly desire and arousal. We look forward to discussing the program's further development with the FDA, including future dose-ranging studies to improve the drug's benefit/risk profile," stated Dr. Trevor Hallam, Executive Vice President of Research & Development for Palatin.

Study Highlights

The trial was double-blinded, placebo-controlled and enrolled 76 premenopausal and 87 postmenopausal women who were followed for one month to determine their baseline level of sexual dysfunction. The patients were then randomized to receive IN doses of either placebo or 10 mg of bremelanotide. Changes in their level of sexual function were assessed over a two month period using the Female Sexual Encounter Profile (FSEP), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Score (FSDS). The first dose was given in the clinic. Prespecified changes in blood pressure, as well as emesis, led to mandatory discontinuation. All endpoints were exploratory without preset statistical goals.

Postmenopausal Patient Efficacy Results

In the Intention-to-Treat Population, the bremelanotide treated postmenopausal women showed statistically significant improvements, compared to baseline and placebo, in desire and arousal success rates, and overall satisfaction at one and two months. In these patients, the FSFI domains of arousal, desire and orgasm were statistically significantly improved compared to placebo at one month. The arousal and orgasm domains were statistically significantly improved compared to placebo at one and two months.

Premenopausal Patient Efficacy Results

In the Intention-to-Treat Population, the bremelanotide treated premenopausal women showed statistically significant improvements, compared to baseline, in desire and arousal success rates, and overall satisfaction at one and two months. However, while there was a consistent trend to greater improvement in these measures in bremelanotide patients compared to placebo treated patients, the differences were not statistically significant between bremelanotide and placebo treated patients because the placebo responses were themselves statistically significantly improved compared to baseline.

Pre- and Postmenopausal Safety Results

Adverse events where the incidence was higher than the incidence associated with placebo primarily included nausea, emesis, flushing, blood pressure increase, headache and nasal symptoms. There were no serious adverse events related to bremelanotide. The most common cause for mandatory discontinuation was protocol-specified blood pressure increase criteria.

Preliminary Conclusions

Based on these data, Palatin is encouraged about the use of bremelanotide for FSAD and believes that future studies in patients with FSAD are warranted. Future dose-ranging studies at 10 mg and lower will be necessary to improve the drug's benefit/risk ratio. Palatin plans to engage the FDA in discussions regarding future development later this calendar year.

Dr. Eileen Palace, The Center for Sexual Health, Metairie, LA, stated, "With no approved medical therapies to treat patients with FSAD, I believe the results of the clinical trials with bremelanotide warrant further development." Dr. Palace is an investigator who enrolled patients in the study and a member of the Bremelanotide Scientific Advisory Board.

Palatin's executive management will present additional detail of the results of this study at future scientific meetings.

About Female Sexual Dysfunction (FSD)

FSD includes four disorders, hypoactive sexual desire disorder, female sexual arousal disorder, dyspareunia and anorgasmia. To establish a diagnosis of FSD, these syndromes must be associated with personal distress, as determined by the affected woman. A February 10, 1999 study published in the Journal of the American Medical Association, titled, "Sexual Dysfunction in the United States: Prevalence and Predictors," states that approximately 43 percent of the postmenopausal female population suffers from some form of FSD.