Are you ready for news regarding new drug? Approved by FDA!? Here it is: Osphena! No jokes - the drug is approved to treat women experiencing pain during sexual intercourse.
The drug treats dyspareunia, a symptom of vulvar and vaginal atrophy (VVA)
associated with declining levels of oestrogen during menopause. Osphena,
(ospemifene) is a pill taken with food once-daily which acts like oestrogen on
vaginal tissues to make them thicker and less fragile.
The approval is based on three studies of 1,889 postmenopausal women who were
randomly assigned to receive Osphena or placebo. After 12 weeks of treatment,
results from the first two trials showed a statistically significant improvement
of dyspareunia in Osphena-treated women and data from the third 52-week study
support its long-term safety.
Osphena's green light comes with a boxed warning which notes that the drug
can stimulate the lining of the uterus and cause it to thicken, which is not
normal in ostmenopausal women. Patients should see their doctor if they
experience any unusual bleeding as it may be a sign of endometrial cancer or a
condition that can lead to it. The warning also states the risk of strokes and
deep vein thrombosis.
Shionogi quoted David Portman, director of the Columbus Center for Women's
Health Research in Ohio, as saying that while more than half of all women in the
USA will experience symptoms of VVA at some time in their postmenopausal life,
"the vast majority…are not being treated with a prescription medication because
women and their healthcare professionals are not proactively discussing the
condition, and its associated symptoms". He added that as an oral medication
taken once-daily, "Osphena is a convenient way for postmenopausal women to help
treat dyspareunia".
VVA is currently treated with vaginally inserted tablets, creams or rings,
which Shionogi has noted can be inconvenient or messy. The Japan-headquartered
drugmaker obtained the rights to Osphena from the USA's QuatRx Pharmaceuticals
in 2010.
Well, everything looks rational. I think that the US market is right one for this drug!
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