479
Views
12
CrossRef citations to date
0
Altmetric
Drug safety evaluation

Evaluation of safety for flibanserin

, &
Pages 1-8 | Received 16 Oct 2019, Accepted 18 Dec 2019, Published online: 23 Dec 2019

References

  • Borsini F, Giraldo E, Monferini E, et al. BIMT 17, a 5-HT2A receptor antagonist and 5-HT1A receptor full agonist in rat cerebral cortex. Naunyn Schmiedebergs Arch Pharmacol. 1995;352:276–282.
  • Borsini F, Ceci A, Bietti G, et al. BIMT 17, a 5-HT1A receptor agonist/5-HT2A receptor antagonist, directly activates postsynaptic 5-HT inhibitory responses in the rat cerebral cortex. Naunyn Schmiedebergs Arch Pharmacol. 1995;352:283–290.
  • Clayton AH, Dennerstein L, Pyke R, et al. Flibanserin: a potential treatment for hypoactive sexual desire disorder in premenopausal women. Womens Health (Lond). 2010;6:639–653.
  • McGahuey CA, Gelenberg AJ, Laukes CA, et al. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000;26:25–40.
  • Parish S, Hahn SR. Hypoactive sexual desire disorder: A review of epidemiology, biopsychology, diagnosis, and treatment. Sex Med Rev. 2016;4:103–120.
  • Parish SJ, Goldstein AT, Goldstein SW, et al. Toward a more evidence-based nosology and nomenclature for female sexual dysfunctions—part II. J Sex Med. 2016;13:1888–1906.
  • Goldstein I, Kim NN, Clayton AH, et al. Hypoactive sexual desire disorder: International Society for the Study of Women’s Sexual Health (ISSWSH) expert consensus panel review. Mayo Clin Proc. 2017;92:114–128.
  • Clayton AH, Goldstein I, Kim NN, et al. The international society for the study of women’s sexual health process of care for management of hypoactive sexual desire disorder in women. Mayo Clin Proc. 2018;93:467–487.
  • Shifren JL, Monz BU, Russo PA, et al. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008;112:970–978.
  • West SL, D’Aloisio AA, Agans RP, et al. Prevalence of low sexual desire and hypoactive sexual desire disorder in a nationally representative sample of US women. Arch Intern Med. 2008;168:1441–1449.
  • Hayes RD, Dennerstein L, Bennett CM, et al. Relationship between hypoactive sexual desire disorder and aging. Fertil Steril. 2007;87:107–112.
  • Leiblum SR, Koochaki PE, Rodenberg CA, et al. Hypoactive sexual desire disorder in postmenopausal women: US results from the Women’s International Study of Health and Sexuality (WISHeS). Menopause. 2006;13:46–56.
  • Foley K, Foley D, Johnson BH. Healthcare resource utilization and expenditures of women diagnosed with hypoactive sexual desire disorder. J Med Econ. 2010;13:583–590.
  • Biddle AK, West SL, D’Aloisio AA, et al. Hypoactive sexual desire disorder in postmenopausal women: quality of life and health burden. Value Health. 2009;12:763–772.
  • Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Womens Health (Larchmt). 2014;23:817–823.
  • Dennerstein L, Koochaki P, Barton I, et al. Hypoactive sexual desire disorder in menopausal women: a survey of Western European women. J Sex Med. 2006;3:212–222.
  • Clayton AH, Maserejian NN, Connor MK, et al. Depression in premenopausal women with HSDD: baseline findings from the HSDD Registry for women. Psychosom Med. 2012;74:305–311.
  • Addyi® (flibanserin) tablets, for oral use [prescribing information in US]. Raleigh, NC: Sprout Pharmaceuticals, Inc.; 2019.
  • Addyi® (flibanserin) tablets, for oral use [product monograph in CANADA]. Raleigh, NC: Sprout Pharmaceuticals, Inc.; 2018.
  • Food and Drug Administration. Addyi tablets - FDA staff reviews, labels and action letters. 2015. cited 2019 Dec 3. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000TOC.cfm.
  • Summary basis of decision – addyi. Health Canada. April 2019. cited 2019 Dec 3. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00392.
  • Woloshin S, Schwartz LM. US food and drug administration approval of flibanserin: even the Score does not add up. JAMA Intern Med. 2016;176:439–442.
  • Anderson R, Moffatt CE. Ignorance is not bliss: if we don’t understand hypoactive sexual desire disorder, how can flibanserin treat it? Commentary. J Sex Med. 2018;15:273–283.
  • Stahl SM. Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorder. CNS Spectr. 2015;20:1–6.
  • Arnow BA, Millheiser L, Garrett A, et al. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Neuroscience. 2009;158:484–502.
  • Bianchi-Demicheli F, Cojan Y, Waber L, et al. Neural bases of hypoactive sexual desire disorder in women: an event-related FMRI study. J Sex Med. 2011;8:2546–2559.
  • Woodard TL, Nowak NT, Balon R, et al. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. Fertil Steril. 2013;100:1068–1076.
  • Pfaus JG. Pathways of sexual desire. J Sex Med. 2009;6:1506–1533.
  • Allers KA, Dremencov E, Ceci A, et al. Acute and repeated flibanserin administration in female rats modulates monoamines differentially across brain areas: a microdialysis study. J Sex Med. 2010;7:1757–1767.
  • Borsini F, Evans K, Jason K, et al. Pharmacology of flibanserin. CNS Drug Rev. 2002;8:117–142.
  • Invernizzi RW, Sacchetti G, Parini S, et al. Flibanserin, a potential antidepressant drug, lowers 5-HT and raises dopamine and noradrenaline in the rat prefrontal cortex dialysate: role of 5-HT(1A) receptors. Br J Pharmacol. 2003;139:1281–1288.
  • Marazziti D, Palego L, Giromella A, et al. Region-dependent effects of flibanserin and buspirone on adenylyl cyclase activity in the human brain. Int J Neuropsychopharmacol. 2002;5:131–140.
  • Stahl SM, Sommer B, Allers KA. Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. J Sex Med. 2011;8:15–27.
  • Brambilla A, Baschirotto A, Grippa N, et al. Effect of flibanserin (BIMT 17), fluoxetine, 8-OH-DPAT and buspirone on serotonin synthesis in rat brain. Eur Neuropsychopharmacol. 1999;10:63–67.
  • Simon JA, Thorp J, Millheiser L. Flibanserin for premenopausal hypoactive sexual desire disorder: pooled analysis of clinical trials. J Womens Health (Larchmt). 2019;28:769–777.
  • Derogatis LR, Komer L, Katz M, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET study. J Sex Med. 2012;9:1074–1085.
  • Katz M, Derogatis LR, Ackerman R, et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med. 2013;10:1807–1815.
  • Thorp J, Simon J, Dattani D, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med. 2012;9:793–804.
  • Sprout Pharmaceuticals. Data on file.
  • Simon JA, Kingsberg SA, Shumel B, et al. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014;21:633–640.
  • Rosen RC, Maserejian NN, Connor MK, et al. Characteristics of premenopausal and postmenopausal women with acquired, generalized hypoactive sexual desire disorder: the hypoactive sexual desire disorder registry for women. Menopause. 2012;19:396–405.
  • Connor MK, Maserejian NN, De Rogatis L, et al. Sexual desire, distress, and associated factors in premenopausal women: preliminary findings from the hypoactive sexual desire disorder registry for women. J Sex Marital Ther. 2011;37:176–189.
  • Johnson-Agbakwu C, Brown L, Yuan J, et al. Effects of flibanserin on the pharmacokinetics of a combined ethinylestradiol/levonorgestrel oral contraceptive in healthy premenopausal women: A randomized crossover study. Clin Ther. 2018;40(1):64–73.
  • Kay GG, Hochadel T, Sicard E, et al. Next-day residual effects of flibanserin on simulated driving performance in premenopausal women. Hum Psychopharmacol. 2017;32:e2603.
  • Stevens DM, Weems JM, Brown L, et al. The pharmacodynamic effects of combined administration of flibanserin and alcohol. J Clin Pharm Ther. 2017;42:598–606.
  • Simon JA, Clayton AH, Parish SJ, et al. Effects of alcohol administered with flibanserin in healthy premenopausal women: A randomized, double-blind, single-dose crossover study. J Sex Med. 2019; In Press. doi: 10.1016/j.jsxm.2019.10.004
  • Simon JA, Clayton AH, Kingsberg SA, et al. Effects of timing of flibanserin administration relative to alcohol intake in healthy premenopausal women: A randomized, double-blind, crossover study. J Sex Med. 2019;16:1779–1786.
  • Millheiser L, Clayton AH, Parish SJ, et al. Safety and tolerability of evening ethanol consumption and bedtime administration of flibanserin in healthy premenopausal female subjects. Sex Med. 2019;7:418–424.
  • Clayton AH, Croft HA, Yuan J, et al. Safety of flibanserin in women treated with antidepressants: A randomized, placebo-controlled study. J Sex Med. 2018;15:43–51.
  • Granzella N, Chen BC, Baird GS, et al. Flibanserin toxicity in a toddler following ingestion. Clin Toxicol. 2018;56:226–228.
  • Vyleesi® [prescribing information]. Waltham, MA, AMAG Pharmaceuticals. Revised June 2019. Accessed 2019 Aug 20
  • Somboonporn W, Davis S, Seif MW, et al. Testosterone for peri- and postmenopausal women. Cochrane Database Syst Rev. 2005;(4):CD004509.
  • Abdallah RT, Simon JA. Testosterone therapy in women: its role in the management of hypoactive sexual desire disorder. Int J Impot Res. 2007;19:458–463.
  • Hubayter Z, Simon JA. Testosterone therapy for sexual dysfunction in postmenopausal women. Climacteric. 2008;11:181–191.
  • Krapf JM, Simon JA. The role of testosterone in the management of hypoactive sexual desire disorder in postmenopausal women. Maturitas. 2009;63:213–219.
  • Davis SR, Braunstein GD. Efficacy and safety of testosterone in the management of hypoactive sexual desire disorder in postmenopausal women. J Sex Med. 2012;9:1134–1148.
  • Davis SR, Wahlin-Jacobsen S. Testosterone in women–the clinical significance. Lancet Diabetes Endocrinol. 2015;3:980–992.
  • Simon J, Braunstein G, Nachtigall L, et al. Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder. J Clin Endocrinol Metab. 2005;90:5226–5233.
  • Dimitrakakis C, Jones R, Liu A, et al. Breast cancer incidence in postmenopausal women using testosterone in addition to usual hormone therapy. Menopause. 2004;11:531–534.
  • Davis SR, Wolfe R, Farrugia H, et al. The incidence of invasive breast cancer among women prescribed testosterone for low libido. J Sex Med. 2009;6:1850–1856.
  • Glaser RL, Dimitrakakis C. Reduced breast cancer incidence in women treated with subcutaneous testosterone, or testosterone with anastrozole: a prospective, observational study. Maturitas. 2013;76:342–349.
  • Segraves RT, Croft H, Kavoussi R, et al. Bupropion sustained release (SR) for the treatment of hypoactive sexual desire disorder (HSDD) in non-depressed women. J Sex Marital Ther. 2001;27:303–316.
  • Wellbutrin® [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline. Revised April 2016. Accessed 2019 Aug 20.
  • BuSpar® [prescribing information]. Princeton, NJ: Bristol-Myers Squibb. Revised May 2017. Accessed 2019 Aug 20.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.