Flibanserin

Flibanserin
Clinical data
Trade namesAddyi
AHFS/Drugs.comMonograph
License data
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability33%[3]
Protein binding~98%
MetabolismExtensive by liver (mainly by CYP3A4 and CYP2C19)
Elimination half-life~11 hours
ExcretionBile duct (51%), kidney (44%)
Identifiers
  • 1-(2-{4-[3-(Trifluoromethyl)phenyl]piperazin-1-yl}ethyl)-1,3-dihydro-2H-benzimidazol-2-one
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.170.970 Edit this at Wikidata
Chemical and physical data
FormulaC20H21F3N4O
Molar mass390.410 g·mol−1
3D model (JSmol)
  • FC(F)(F)c4cc(N3CCN(CCN2c1ccccc1NC2=O)CC3)ccc4
  • InChI=1S/C20H21F3N4O/c21-20(22,23)15-4-3-5-16(14-15)26-11-8-25(9-12-26)10-13-27-18-7-2-1-6-17(18)24-19(27)28/h1-7,14H,8-13H2,(H,24,28) checkY
  • Key:PPRRDFIXUUSXRA-UHFFFAOYSA-N checkY
 ☒NcheckY (what is this?)  (verify)

Flibanserin, sold under the brand name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD).[4][5] The medication improves sexual desire, increases the number of satisfying sexual events, and decreases the distress associated with low sexual desire.[6] The most common side effects are dizziness, sleepiness, nausea, difficulty falling asleep or staying asleep and dry mouth.[6]

Development by Boehringer Ingelheim was halted in October 2010, following a negative evaluation by the US Food and Drug Administration (FDA).[7] The rights to the drug were then transferred to Sprout Pharmaceuticals, which achieved approval of the drug by the US FDA in August 2015.[8]

Addyi is approved for medical use in the US for premenopausal women with HSDD and in Canada for premenopausal and postmenopausal women with HSDD.[6][9]

HSDD was recognized as a distinct sexual function disorder for more than 30 years, but was removed from the Diagnostic and Statistical Manual of Mental Disorders in 2013, and replaced with a new diagnosis called female sexual interest/arousal disorder (FSIAD).[10][11]

  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 October 2023.
  2. ^ "Regulatory Decision Summary for Addyi". 23 October 2014.
  3. ^ a b "Addyi- flibanserin tablet, film coated". DailyMed. 10 October 2019. Retrieved 20 October 2020.
  4. ^ Borsini F, Evans K, Jason K, Rohde F, Alexander B, Pollentier S (2002). "Pharmacology of flibanserin". CNS Drug Reviews. 8 (2): 117–142. doi:10.1111/j.1527-3458.2002.tb00219.x. PMC 6741686. PMID 12177684.
  5. ^ Jolly E, Clayton A, Thorp J, Lewis-D'Agostino D, Wunderlich G, Lesko L (April 2008). "Design of Phase III pivotal trials of flibanserin in female Hypoactive Sexual Desire Disorder (HSDD)". Sexologies. 17 (Suppl 1): S133–4. doi:10.1016/S1158-1360(08)72886-X.
  6. ^ a b c "ADDYI- flibanserin tablet, film coated". DailyMed. 1 September 2021. Retrieved 14 November 2022.
  7. ^ Spiegel online: Pharmakonzern stoppt Lustpille für die Frau, 8 October 2010 (in German)
  8. ^ Mullard A (October 2015). "FDA approves female sexual dysfunction drug". Nature Reviews. Drug Discovery. 14 (10): 669. doi:10.1038/nrd4757. PMID 26424353. S2CID 36380932.
  9. ^ "ADDYI Product Monograph" (PDF). Health Canada. 26 January 2021. Retrieved 14 November 2022.
  10. ^ American Psychiatric Association. Sexual and gender identity disorders. In: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 2000:493–538.
  11. ^ Nagoski E (27 February 2015). "Nothing Is Wrong With Your Sex Drive". The New York Times. Retrieved 31 July 2017.