BETHESDA, MD 27 February 2013—
and Shionogi Inc. (PDF) on February 26 announced the approval of ospemifene oral tablets for the treatment of dyspareunia in postmenopausal women.
The drug, which enhances estrogen activity in some tissues and blocks it in others, will be sold under the brand name Osphena. Shionogi's Florham Park, New Jersey-based U.S. unit has not announced a launch date for the product.
The labeling (PDF) for ospemifene states that the drug is indicated for the treatment of moderate-to-severe pain during intercourse when the symptoms are related to vulvar and vaginal atrophy.
A boxed warning in the labeling describes an increased risk of endometrial hyperplasia and cancer in women treated with unopposed estrogen therapy. Estrogen monotherapy also increases the risk of stroke and deep vein thrombosis (DVT), according to the boxed warning.
The labeling states that clinicians should consider prescribing a progestin to postmenopausal women with an intact uterus who are treated with estrogenic drugs. Women without a uterus do not need a progestin.
The use of ospemifene is contraindicated in women with undiagnosed abnormal genital bleeding, known or suspected estrogen-dependent neoplasia, or active DVT, pulmonary embolism, or thromboembolic disease or a history of these conditions. Ospemifene can cause fetal harm and is contraindicated in women who are or may become pregnant.
The labeling advises women to use ospemifene for the shortest duration of time consistent with individual risks and treatment goals.
Concomitant use of ospemifene and fluconazole, rifampin, estrogen agonists, or estrogen antagonists is not recommended.
In clinical studies, the most commonly reported adverse events associated with the use of ospemifene were hot flashes, vaginal discharge, muscle spasms, genital discharge, and excessive sweating.
The recommended dosage of ospemifene is one 60-mg tablet taken once daily with food.
Ospemifene will be supplied as 60-mg film-coated tablets packaged in bottles of 100 and in blister packs containing a total of 30 tablets. The tablets should be stored at controlled room temperature.