Ospemifene

Ospemifene
Clinical data
Trade names	Osphena, Senshio
Other names	Deaminohydroxytoremifene
License data	US DailyMed: Ospemifene;
Routes of; administration	By mouth
Drug class	Selective estrogen receptor modulator
ATC code	G03XC05 (WHO) ;
Legal status
Legal status	CA: ℞-only; US: WARNINGRx-only; EU: Rx-only;
Identifiers
	IUPAC name 2-(p-((Z)-4-chloro-1,2-diphenyl-1-butenyl)phenoxy)ethanol;
CAS Number	128607-22-7;
PubChem CID	3036505;
DrugBank	DB04938;
ChemSpider	2300501;
UNII	B0P231ILBK;
KEGG	D08958;
ChEBI	CHEBI:73275;
ChEMBL	ChEMBL2105395;
CompTox Dashboard (EPA)	DTXSID101025426 ;
ECHA InfoCard	100.190.672
Chemical and physical data
Formula	C24H23ClO2
Molar mass	378.90 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1;
	InChI InChI=1S/C24H23ClO2/c25-16-15-23(19-7-3-1-4-8-19)24(20-9-5-2-6-10-20)21-11-13-22(14-12-21)27-18-17-26/h1-14,26H,15-18H2/b24-23-; Key:LUMKNAVTFCDUIE-VHXPQNKSSA-N;

Ospemifene (brand names Osphena and Senshio produced by Shionogi) 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)^[4] 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."^[5]

The medication was approved by the FDA in February 2013^[6] and by the European Commission for marketing in the EU in January 2015.^[7]

^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
^ "Summary Basis of Decision (SBD) for Osphena". Health Canada. 23 October 2014. Retrieved 29 May 2022.
^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
^ Rutanen EM, Heikkinen J, Halonen K, Komi J, Lammintausta R, Ylikorkala O (2003). "Effects of ospemifene, a novel SERM, on hormones, genital tract, climacteric symptoms, and quality of life in postmenopausal women: a double-blind, randomized trial". Menopause. 10 (5): 433–9. doi:10.1097/01.GME.0000063609.62485.27. PMID 14501605. S2CID 25481518.
^ Tanzi MG (April 2013). "Ospemifene: New treatment for postmenopausal women". Pharmacy Today. American Pharmacists Association. Archived from the original on 2017-12-01. Retrieved 2013-12-02.
^ "FDA approves Osphena for postmenopausal women experiencing pain during sex". FDA News Release. U.S. Food and Drug Administration. 2013-02-26.
^ "European Medicines Agency".

[FDA-AllBoxedWarnings-1] "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.

[2] "Summary Basis of Decision (SBD) for Osphena". Health Canada. 23 October 2014. Retrieved 29 May 2022.

[3] "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.

[pmid14501605-4] Rutanen EM, Heikkinen J, Halonen K, Komi J, Lammintausta R, Ylikorkala O (2003). "Effects of ospemifene, a novel SERM, on hormones, genital tract, climacteric symptoms, and quality of life in postmenopausal women: a double-blind, randomized trial". Menopause. 10 (5): 433–9. doi:10.1097/01.GME.0000063609.62485.27. PMID 14501605. S2CID 25481518.

[test-5] Tanzi MG (April 2013). "Ospemifene: New treatment for postmenopausal women". Pharmacy Today. American Pharmacists Association. Archived from the original on 2017-12-01. Retrieved 2013-12-02.

[6] "FDA approves Osphena for postmenopausal women experiencing pain during sex". FDA News Release. U.S. Food and Drug Administration. 2013-02-26.

[7] "European Medicines Agency".

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