Palatin Technologies, Inc. (NYSE MKT: PTN) presented new analyses from its Phase 2b clinical trial of bremelanotide, which demonstrated dose-dependent improvements in sexual desire and treatment satisfaction in premenopausal women with hypoactive sexual desire disorder (HSDD) and combined HSDD/female sexual arousal disorder (FSAD), both which are forms of female sexual dysfunction (FSD).1,2,3
The data from three clinical abstracts were presented Saturday, February 22, 2014 at the International Society for the Study of Women’s Sexual Health (ISSWSH) conference in San Diego. Bremelanotide is a first-in-class, investigative melanocortin agonist being developed for treatment of female sexual dysfunction (FSD).
“We are excited by the potential that bremelanotide may offer women in treating HSDD, a condition that has been recognized for more than 30 years but for which there is no FDA-approved therapy,” said Carl Spana, Ph.D., President and CEO of Palatin. “Unlike other investigational therapies in development for FSD, bremelanotide is an on-demand medication that has been shown to work within 30 to 60 minutes of administration. That would allow women to take it when they need it, providing them with a quick response, greater control and flexibility in their treatment.”
In one abstract, responder analyses showed bremelanotide had a statistically significant increase in the percentage of women whose total score on the Female Sexual Function Index (FSFI) – a measure of overall sexual functioning – improved: 69% for 1.75 mg versus 46% for placebo (p1 In addition, a significantly higher percentage of women on bremelanotide versus placebo achieved at least one satisfying sexual event (SSE): 55% for 1.75 mg versus 37% for placebo (p1
A second abstract, presenting data from the episodic questionnaire, Female Sexual Encounter Profile – Revised (FSEP-R), demonstrated greater mean increases in SSEs within 24 hours of dosing with bremelanotide 1.75 mg (mean increase: 0.7; p=0.0443) versus placebo (mean increase: 0.1). As-needed administration of bremelanotide 1.75 mg versus placebo also demonstrated episodic increases in levels of desire (0.4 vs. 0.0, respectively) and in the women’s satisfaction with their levels of desire (0.6 vs. 0.1, respectively).2
In a third abstract, data collected from the Women’s Inventory of Treatment Satisfaction (WITS-9) showed women who completed treatment were significantly more satisfied with bremelanotide 1.75 mg (0.77; p=0.0204) versus placebo (0.17).3
“Additional analyses continue to yield robust, positive data for bremelanotide, which shows promise in addressing an important unmet need for women living with HSDD,” said David J. Portman, MD, Principal Investigator at the Columbus Center for Women’s Health Research, and in private practice with Portman Obstetrics and Gynecology. “The findings from these abstracts show that bremelanotide can significantly improve desire and sexual functioning. More importantly, women were satisfied with treatment, which is a predictor not just of satisfaction but with compliance and the continuation of treatment.”
Bremelanotide was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 394 patients. Adverse events that most commonly led to discontinuation were nausea and emesis. No serious adverse events were attributed to bremelanotide during the trial.
Palatin anticipates commencing enrolling patients in Phase 3 clinical trials in the second half of this year.
Details of the trial results presented at the ISSWSH conference are included in the following presentations, which are available for viewing on Palatin’s website (www.palatin.com):
- Presentation #20 titled, “Subcutaneous Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: Responder Analyses Based on Receiver Operating Characteristics Curves”1
- Presentation #21 titled, “Episodic Efficacy with Subcutaneous Bremelanotide Self-Administered at Home By Premenopausal Women with Female Sexual Dysfunction as Measured by the Female Sexual Encounter Profile-Revised”2
- Presentation #19 titled, “Treatment Satisfaction with Subcutaneous Bremelanotide Self-Administered at Home By Premenopausal Women with Female Sexual Dysfunction: A Placebo-Controlled Dose-Ranging Study”3
Study Design1,2,3
Approximately 400 premenopausal women diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both were enrolled in this multi-centered, randomized, placebo-controlled, parallel-group dose-ranging trial. Patients were treated for 16 weeks and randomized to one of four double-blind treatment groups receiving placebo or subcutaneous (SC) bremelanotide doses of 0.75, 1.25, or 1.75 milligrams.
The objectives of the Phase 2b trial were to demonstrate and identify safe and effective SC fixed doses of bremelanotide intended for on-demand use in premenopausal females with FSD, and to define endpoint measurements to support transition to Phase 3 clinical studies and activities.
About Female Sexual Dysfunction
Female sexual dysfunction (FSD) is often described as a disturbance in sexual functioning.4 It is multi-dimensional and can be caused by physiological, psychological, emotional and/or relational factors.5 FSD can have a major impact on a woman’s sexual relationships, interpersonal relationships, quality of life, and even their general wellbeing.6
There are four main types of FSD: Sexual Desire Disorders, Female Sexual Arousal Disorder (FSAD), Female Orgasmic Disorder (FOD) and Sexual Pain Disorders. Hypoactive Sexual Desire Disorder (HSDD) is one type of sexual desire disorder.7
The most common type of FSD is HSDD, characterized by a lack of sexual thoughts and desire for sexual activity, which causes a woman distress or puts a strain on the relationship with her partner, and cannot be accounted for by another medical, physical or psychiatric condition.8 It is estimated that one in 10 women may have the signs of HSDD.9
There are no drugs in the United States approved for the treatment of HSDD. Bremelanotide is an on-demand treatment and has the potential to transform the treatment of patients with HSDD.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin’s website at http://www.palatin.com.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc. such as statements about clinical trial results, potential actions by regulatory agencies including the U.S. Food and Drug Administration (FDA), regulatory plans, development programs, proposed indications for product candidates and market potential for product candidates, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, Palatin’s ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin’s products, and other factors discussed in Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
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