Shionogi wins FDA approval on Osphena for painful sex
The FDA has approved Shionogi's Osphena (ospemifene), an oral therapy designed to prevent painful intercourse for postmenopausal women. The agency's OK gives Shionogi a green light to market the treatment for moderate to severe dyspareunia--painful intercourse--a symptom of vulvar and vaginal atrophy (VVA).
Osphena, an estrogen receptor modulator, is the first oral alternative to vaginal or oral estrogens approved in the U.S. to treat painful intercourse due to menopause, says Japan's Shionogi. And while not often discussed, the potential market is huge: 32 million women in the U.S. suffer from the condition.
"Dyspareunia is among the problems most frequently reported by postmenopausal women," said Dr. Victoria Kusiak, the deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Osphena provides an additional treatment option for women seeking relief."
"While more than half of all women in the U.S. will experience symptoms of VVA at some time in their postmenopausal life, the vast majority of women with VVA are not being treated with a prescription medication because women and their healthcare professionals are not proactively discussing the condition and its associated symptoms," said David J. Portman, the director of the Columbus Center for Women's Health Research. The drug has not yet been priced.
Ann Arbor, MI-based QuatRx Pharmaceuticals licensed out rights to the drug back in 2010--after it had completed Phase III studies--for a modest $25 million upfront and more than $100 million in milestones.
Another selective estrogen receptor modulator, bazedoxifene, is currently under review by the FDA. Pfizer won control of the drug with its acquisition of Wyeth, which in-licensed it from Ligand.