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Shionogi files NDA for ospemifene as treatment for vulvar, vaginal atrophy

Wednesday, May 09 2012 | Comments
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Shionogi Inc., the U.S. subsidiary of Shionogi & Co. Ltd., submitted a New Drug Application to the Food and Drug Administration for ospemifene 60 mg tablets for the treatment of vulvar and vaginal atrophy (VVA) due to menopause.

According to Shionogi, VVA is a chronic and progressive condition characterized by symptoms such as dyspareunia (pain during sexual intercourse), vaginal dryness and irritation. Declining levels of estrogen during menopause can cause the tissues of the vaginal lining to thin and lose elasticity, the firm noted, adding that dryness and irritation associated with reductions in vaginal secretions frequently lead to pain or bleeding during sexual intercourse.

Phase III trials of the drug as a treatment for VVA showed that ospemifene led to statistically significant improvements in co-primary endpoints, including improvement in moderate to severe symptoms of dyspareunia and vaginal dryness, a decrease in the percentage of parabasal cells, an increase in the percentage of superficial cells from a vaginal smear and a decrease in vaginal pH among postmenopausal women.

The drug is a selective estrogen receptor modulator that is designed to mimic the effects of estrogen on the vaginal epithelium. If approved, ospemifene would be the first nonestrogen treatment for VVA.

Shionogi licensed the worldwide marketing rights to ospemifene from QuatRx Pharmaceuticals Co. in 2010.

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