Japan's Shionogi says that the US Food and Drug Administration has agreed to review ospemifene for the treatment of vulvar and vaginal atrophy (VVA) due to menopause.
The drug has been filed for moderate to severe symptoms of dyspareunia (painful sexual intercourse) and/or vaginal dryness and physiological changes. Ospemifene is a selective oestrogen receptor modulator for VVA which has the potential to become the first oral treatment alternative to vaginal oestrogens.
The submission includes data from three Phase III trials involving 2,100 postmenopausal women with VVA. In the first of those, ospemifene met all co-primary endpoints at a 60mg dosage and demonstrated statistically significant improvements in dyspareunia and/or vaginal dryness.
John Keller, president of Shionogi's US unit, said that "women spend more than a third of their lives in menopause, yet VVA is an underdiagnosed and undertreated condition that significantly impacts the health and well-being of women. More than 7.1 million women are diagnosed with VVA each year, and only 11% are treated with a prescription medication.
Currently, the most common treatments are vaginally inserted tablets, creams or rings, all of which can be inconvenient or messy, Shionogi concluded. The firm expects to launch ospemifene, licensed from QuatRx Pharmaceuticals in March 2010, in the USA in the second or third quarter of 2013.