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.
Her role will perfectly complement the advocacy work we've done on behalf of the 16 million American women struggling with HSDD
," said Susan Scanlan, Chair of Even the Score.
An estimated 1 in 10 women may have HSDD
at some point in their life, for which therapies like flibanserin with a 9%- 13% responder rate over placebo, and S1 Biopharma's first in class, next-generation drug Lorexys have been developed to address.
The Advisory Committee's recommendation has historic repercussions -- first, for the 1-in-10 women who are living with HSDD
without a single approved medical treatment for their condition.
In a breakthrough moment for women's health, the FDA today chose to respect the science and stand with millions of American women by approving the first-ever medical treatment option for HSDD
If approved, ADDYI will be the first FDA-approved treatment for HSDD
The patent covers methods for treating FSD and HSDD
and also includes using a metered dosage device to deliver the defined dose of the testosterone formulation in LibiGel.
Sprout is pursuing the FDA approval of flibanserin to treat HSDD
in premenopausal women, for which there is currently no FDA-approved treatment.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD
in menopausal women.
NYSE Amex: PTN) - Today's 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.
By comparison, the drug currently being considered by the FDA as a potential first-ever treatment for women's HSDD
-- called flibanserin -- "has not been afforded the same priority despite having much less severe side effects," which most commonly include sleepiness, dizziness and nausea.
These levels also were similar to those reported in the two pivotal testosterone patch (Intrinsa) studies which showed efficacy in treating HSDD
in estrogen-treated surgically menopausal women, which were 4.