Several Osphena studies with contribution by 4Pharma have been published recently

Jouni Vuorinen (jouni.vuorinen a, Feb 26th 2014

Osphena (Ospemifene) is an oral medication indicated for the treatment of dyspareunia – pain during sexual intercourse – encountered by some women, more often in those who are post-menopausal. Ospemifene is a selective estrogen receptor modulator (SERM) acting similarly to an estrogen on the vaginal epithelium, building vaginal wall thickness which in turn reduces the pain associated with dyspareunia. Dyspareunia is most commonly caused by ‘vulvar and vaginal atrophy’.

Osphena was developed by Hormos Medical Oy/QuatRx Pharmaceuticals and is being commercialized by Shionogi. The medication was approved by the FDA in February 2013. Although the postmenopausal vaginal atrophy market has experienced anemic growth over the past decade, it is expected to undergo a considerable change in the near future. GlobalData expects the launch of Osphena to be a major market-driving event, and the total sales for this first-in-class oral SERM are expected to reach $319 million across the major markets in 2022.

  • Koskimies P, Katila K, Lammintausta R, Aaltonen A-M, Vuorinen J, Saarni O and Scheinin M: Oral bioavailability of ospemifene improves with food intake. International Journal of Clinical Pharmacology and Therapeutics; 51(10): 787-94, 2013.
  • Koskimies P, Turunen J, Lammintausta R and Scheinin M: Single-dose and steady-state pharmacokinetics of ospemifene, a selective estrogen receptor modulator, in postmenopausal women. International Journal of Clinical Pharmacology and Therapeutics; 51(11): 861-7, 2013.
  • Turpeinen M, Uusitalo J, Lehtinen T, Kailajärvi M, Pelkonen O, Vuorinen J, Tapanainen P, Stjernschantz C, Lammintausta R and Scheinin M: Effects of ospemifene on drug metabolism mediated by cytochrome P450 enzymes in humans in vitro and in vivo. International Journal of Molecular Sciences; 14(7): 14064-75, 2013.
  • Lehtinen T, Tolonen A, Turpeinen M, Uusitalo J, Vuorinen J, Lammintausta R, Pelkonen O and Scheinin M: Effects of cytochrome P450 inhibitors and inducers on the metabolism and pharmacokinetics of ospemifene. Biopharmaceutics & Drug Disposition; 34(7): 387-95, 2013.