Palatin applauds FDA's approval of flibanserin for women living with hypoactive sexual desire disorder

Palatin Technologies, Inc. (NYSE MKT: PTN) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential. Palatin's lead product under development is bremelanotide for the treatment of female sexual dysfunction (FSD).

The approval of flibanserin (under development by Sprout Pharmaceuticals) today by the U.S. Food and Drug Administration (FDA) marks a long-awaited milestone in healthcare for women. The FDA's approval of flibanserin validates that there is an important need for women living with hypoactive sexual desire disorder, or HSDD, to have an approved treatment option. Palatin applauds the FDA's positive determination, which supports FDA's previous statements that HSDD is an unmet medical need requiring a safe treatment option for women with HSDD.

HSDD is a medical condition marked 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, or as a result of other medication. It is estimated that one in 10 women may have the signs of HSDD at some point in their life, and as such HSDD represents a major opportunity to address a tremendous medical need with therapies like flibanserin and bremelanotide.

Palatin Technologies is continuing the development of bremelanotide, a first-in-class, as needed, melanocortin-4 receptor agonist being studied for the treatment of HSDD in pre-menopausal women, so that these women suffering from HSDD have multiple treatment options in the future. Bremelanotide has a novel mechanism that activates endogenous pathways in the brain involved in creating a sexual response. Unlike flibanserin or certain other FSD treatments in development that require daily administration, bremelanotide is an as-needed (not chronic), centrally-mediated medication. Studies have shown that bremelanotide starts working within 30 to 60 minutes of administration and remains effective for approximately eight hours, providing women with greater control and flexibility in their treatment as well as a quick response. By comparison, flibanserin must be taken daily and may take up to several weeks of continuous daily use before an effect of increased sexual desire is seen. The differing dose frequency and route of administration, if available in the marketplace at the same time, could provide a robust set of treatment options for women suffering from HSDD.

Palatin Technologies is excited to continue working toward bringing bremelanotide as a treatment for HSDD closer to a reality, expanding the HSDD marketplace and providing women with multiple options. Palatin Technologies is currently enrolling pre-menopausal women with HSDD into its Phase III trials for bremelanotide, and anticipates completing enrollment for the trials by the end of this year. Each pivotal trial of the reconnect study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. The clinical trials are designed to randomize approximately 1100 women (~550 each trial) to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) as an on-demand, as-needed treatment.