Shionogi Wins U.S. Backing for Menopause Side Effect Drug

Shionogi & Co., the Japanese maker of the Crestor cholesterol pill, won U.S. approval of its treatment for painful sex caused by menopause.

The Food and Drug Administration cleared the drug Osphena for post-menopausal women whose thinning vaginal tissues lead to dyspareunia, or painful intercourse, the agency said today in a statement. The pill, chemically known as ospemifene, would be the first oral treatment for the condition, which is currently treated with lubricants or estrogen-based suppositories.

No product is marketed specifically for this use and Shionogi’s Osphena may generate $495 million in sales in 2017, Naomi Kumagai, an analyst with Jefferies & Co. in Tokyo, said in an e-mail before the announcement. More than 7.1 million women are diagnosed annually with vulvar and vaginal atrophy, Osaka, Japan-based Shionogi said in June.

“Dyspareunia is among the problems most frequently reported by post-menopausal women,” Victoria Kusiak, a deputy director for a branch of the FDA’s Center for Drug Evaluation and Research, said in the statement. “Osphena provides an additional treatment option for women seeking relief.”

Shionogi’s once-daily pill acts like estrogen on vaginal tissues to make them thicker and less fragile, the FDA said.

Pfizer Inc. and Ligand Pharmaceuticals Inc. have a similar drug, bazedoxifene, under FDA review that also seeks to reduce hot flashes and prevent osteoporosis in post-menopausal women. The agency is scheduled to decide by Oct. 3 whether New York-based Pfizer and Ligand, based in La Jolla, California, can market their treatment in the U.S.

Shionogi’s Osphena will carry a boxed warning that the drug can stimulate the lining of the uterus and cause it to thicken, which typically occurs before menstruation. Postmenopausal women don’t menstruate and women should see their doctor if they experience unusual bleeding since it may be a sign of endometrial cancer, the FDA said.