FDA, disparüni tedavisi için tabletlere onay verdi (İng)

FDA approves Shionogi’s Osphena tablets to treat dyspareunia

PBR Staff Writer Published 27 February 2013

Food and Drug Administration (FDA) has approved US-based pharmaceutical company Shionogi’s Osphena (ospemifene) tablets for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.

Osphena is an estrogen agonist/antagonist drug, which is the first and only oral treatment alternative to vaginal or oral steroidal estrogens for women with dyspareunia due to menopause, and comes with tissue selective effects.

The drug’s biological activities are mediated through binding to estrogen receptors, which results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism).

Osphena’s efficacy and safety was evidenced in three clinical trials, in which it has shown significant improvements in dyspareunia (painful intercourse) as well as on the physical changes of the vagina associated with menopause.

The improvements include increased superficial cells and decreased parabasal cells and vaginal pH.

Shionogi president and chief executive officer John Keller said the FDA approval of Osphena represents an important advancement in the treatment of dyspareunia, providing an alternative treatment option for the millions of women suffering with such condition.

“We look forward to building our product portfolio in women’s health by advancing important therapies, such as Osphena™,” Keller added.

Shionogi in 2010, entered into a license agreement w ith QuatRx Pharmaceuticals and obtained exclusive global marketing rights to Osphena.