Ophena is filed by Shionogi Inc at FDA for Vaginal Atrophy

Shionogi Inc. has submitted a new drug application to the FDA for Ophena (ospemifene),an oral selective oestrogen receptor modulator licensed from QuatRx Pharmaceuticals The FDA filing is for a 60mg tablet formulation for the treatment of vulvular and vaginal atrophy in post-menopausal women, including moderate to severe symptoms of dyspareunia (painful intercourse) and/or vaginal dryness and physiological changes such as changes in parabasal/superficial cells and pH.