title: Ospemifene: first global approval.
abstract: Ospemifene (Osphena™) is an oral selective estrogen receptor modulator (SERM), with tissue-specific estrogenic agonist/antagonist effects. QuatRx Pharmaceuticals conducted the global development of the agent before licensing it to Shionogi for regulatory filing and commercialization worldwide. Ospemifene is the first non-estrogen treatment approved for moderate to severe dyspareunia in women with menopause-related vulvar and vaginal atrophy. The drug is approved in the USA, and application for EU regulatory approval is underway. This article summarizes the milestones in the development of ospemifene leading to this first approval for moderate to severe dyspareunia, a symptom of postmenopausal vulvar and vaginal atrophy.
authors.affiliation: Adis R&D Insight, 41 Centorian Drive, Private Bag 65901 Mairangi Bay, North Shore 0754, Auckland, New Zealand. dru@adis.com
authors.forename: Shelley
authors.initials: S
authors.lastname: Elkinson
authors.forename: Lily P H
authors.initials: LP
authors.lastname: Yang
mesh_terms: D000818:Animals; D001284:Atrophy; D002986:Clinical Trials as Topic / Q000379:methods; D017277:Drug Approval / Q000379:methods*; D004345:Drug Industry / Q000379:methods; D004414:Dyspareunia / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D017698:Postmenopause / Q000187:drug effects / Q000378:metabolism; D020845:Selective Estrogen Receptor Modulators / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013629:Tamoxifen / Q000031:analogs & derivatives* / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use; D014623:Vaginal Diseases / Q000175:diagnosis / Q000188:drug therapy / Q000473:pathology; D014844:Vulva / Q000473:pathology
chemical_list: D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene