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news.Palatin Technologies - FDA Advisory Committee's recommendation for the approval of flibanserin is an important step forward in women's health, as the decision addresses the important need for the women living with hypoactive sexual desire disorder, or HSDD, to have an approved treatment option
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HSDD is a medical condition marked by a lack of sexual thoughts and desire for sexual activity, and cannot be accounted for by another medical physical or psychiatric condition, or a substance-like 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 excited to continue 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. Bremelanotide has a novel mechanism that activates endogenous pathways in the brain involved in creating a sexual response. It is unique because bremelanotide is an as-needed (not chronic), centrally-mediated medication. Studies have shown that it 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.
Palatin Technologies is currently enrolling premenopausal women in Phase 3 clinical trials in North America, studying bremelanotide as an as-needed treatment for HSDD.