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Drug Profile

Pitolisant for treating patients with narcolepsy

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Pages 79-84 | Received 20 Oct 2019, Accepted 08 Jan 2020, Published online: 23 Jan 2020

References

  • Chaiard J, Weaver TE. Update on research and practices in major sleep disorders: part II-insomnia, Willis-Ekbom disease (restless leg syndrome), and narcolepsy. J Nurs Scholarsh. 2019;51(6):624-633.
  • Scammell TE. Narcolepsy. N Engl J Med. 2015;373(27):2654.
  • Scheer D, Schwartz SW, Parr M, et al. Prevalence and incidence of narcolepsy in a US health care claims database, 2008-2010. Sleep. 2019;42(7):zsz091.
  • Bassetti CLA, Adamantidis A, Burdakov D, et al. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019 Sep;15(9):519–539.
  • Franceschini C, Pizza F, Antelmi E, et al. Narcolepsy treatment: pharmacological and behavioral strategies in adults and children. Sleep Breath. 2019 Jul 10. [Epub ahead of print].
  • Reading PJ. Update on narcolepsy. J Neurol . 2019;266(7):1809–1815.
  • de Biase S, Gigli GL, Valente M. Important decisions in choosing the pharmacotherapy for narcoleptics. Expert Opin Pharmacother . 2019;20(5):483–486.
  • Tiligada E, Ennis M. Histamine pharmacology: from Sir Henry Dale to the 21st century. Br J Pharmacol. 2018 Oct 19. [Epub ahead of print].
  • Bassetti CL, Baumann CR, Dauvilliers Y, et al. Cerebrospinal fluid histamine levels are decreased in patients with narcolepsy and excessive daytime sleepiness of other origin. J Sleep Res. 2010;19(4):620–623.
  • Franco P, Dauvilliers Y, Inocente CO, et al. Impaired histaminergic neurotransmission in children with narcolepsy type 1. Impaired histaminergic neurotransmission in children with narcolepsy type 1. CNS Neurosci Ther. 2019;25(3):386–395.
  • Romigi A, Vitrani G, Lo Giudice T, et al. Profile of pitolisant in the management of narcolepsy: design, development, and place in therapy. Drug Des Devel Ther. 2018;12:2665.
  • U.S. Food and Drug Administration. Clinical review. [cited 2019 Oct 14]. Available from. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000MedR.pdf.
  • U.S. Food and Drug Administration. WAKIX (pitolisant) tablets, for oral use. [cited 2019 Oct 14]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211150s000lbl.pdf.
  • Reading P. Cataplexy. Pract Neurol. 2019;19(1):21–27.
  • Szabo ST, Thorpy MJ, Mayer G, et al. Neurobiological and immunogenetic aspects of narcolepsy: implications for pharmacotherapy. Sleep Med Rev. 2019;43:23–26.
  • Abad VC. An evaluation of sodium oxybate as a treatment option for narcolepsy. Expert Opin Pharmacother . 2019;20(10):1189–1199.
  • Barateau L, Lopez R, Dauvilliers Y. Management of Narcolepsy. Curr Treat Options Neurol. 2016;18(10):43.
  • Barateau L, Lopez R, Dauvilliers Y. Treatment options for narcolepsy. CNS Drugs. 2016;30(5):369–379.
  • Abad VC, Guilleminault C. New developments in the management of narcolepsy. Nat Sci Sleep. 2017;9:39–47.
  • Barateau L, Lopez R, Dauvilliers Y. Management of narcolepsy. Curr Treat Options Neurol. 2016;18(10):43.
  • Carter LP, Henningfield JE, Wang YG, et al. A randomized, double-blind, placebo-controlled, crossover study to evaluate the human abuse liability of solriamfetol,a selective dopamine and norepinephrine reuptake inhibitor. J Psychopharmacol. 2018;32(12):1351–1361.
  • Bogan RK, Feldman N, Emsellem HA, et al. of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy. Sleep Med. 2015;16(9):1102–1108.
  • Yang J, Gao J. Solriamfetol for the treatment of excessive daytime sleepiness associated with narcolepsy. Expert Rev Clin Pharmacol. 2019;12(8):723–728.
  • U.S. Food and Drug Administration. SUNOSI (solriamfetol) tablets, for oral use. [cited 2019 Oct 14]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
  • Thorpy MJ, Shapiro C, Mayer G, et al. Randomized study of solriamfetol for excessive sleepiness in narcolepsy. Ann Neurol. 2019;85(3):359–370.
  • Mahoney CE, Cogswell A, Koralnik IJ. et al. The neurobiological basis of narcolepsy. Nat Rev Neurosci. 2019;20(2):83–93.
  • Wang C, Wang Q, Ji B, et al. The orexin/receptor system: molecular mechanism and therapeutic potential for neurological diseases. Front Mol Neurosci. 2018;11:220.
  • Nepovimova E, Janockova J, Misik J, et al. Orexin supplementation in narcolepsy treatment: A review. Med Res Rev. 2019 May;39(3):961–965.
  • Burgess CR. Histamine and orexin in the control of arousal, locomotion, and motivation. J Neurosci. 2010. 24. 30(8):2810–2811.
  • Riddy DM, Cook AE, Shackleford DM, et al. Drug-receptor kinetics and sigma-1 receptor affinity differentiate clinically evaluated histamine H3 receptor antagonists. Neuropharmacology. 2019;144:244–245.
  • Calik MW. Update on the treatment of narcolepsy: clinical efficacy of pitolisant. Nat Sci Sleep. 2017;9:127–133.
  • Baumann CR. Wide implications of a trial on pitolisant for cataplexy. Lancet Neurol. 2017;16(3):173–174.
  • Schwartz JC. The histamine H3 receptor: from discovery to clinical trials with pitolisant. Br J Pharmacol. 2011;163(4):713–721.
  • Ligneau X, Landais L, Perrin D, et al. Brain histamine and schizophrenia: potential therapeutic applications of H3-receptor inverse agonists studied with BF2.649. Biochem Pharmacol. 2007;73(8):1215–1224.
  • Inocente C, Arnulf I, Bastuji H, et al. Pitolisant, an inverse agonist of the histamine H3 receptor: an alternative stimulant for narcolepsy cataplexy in teenagers with refractory sleepiness. Clin Neuropharmacol. 2012;35(2):55.
  • Kollb-Sielecka M, Demolis P, Emmerich J, et al. The European medicines agency review of pitolisant for treatment of narcolepsy: summary of the scientific assessment by the committee for medicinal products for human use. Sleep Med. 2017;33:125–129.
  • Ghamari N, Zarei O, Arias-Montaño JA, et al. Histamine H receptor antagonists/inverse agonists: where do they go? Pharmacol Ther. 2019;200:69–74.
  • Scolnick B. Antihistamine agents and pitolisant might be useful for anorexia nervosa. Med Hypotheses. 2019;132:109342.
  • Ligneau X, Shah RR, Berrebi-Bertrand I, et al. Nonclinical cardiovascular safety of pitolisant: comparing international conference on harmonization S7B and comprehensive in vitro proarrhythmia assay initiative studies. Br J Pharmacol. 2017;174(23):4449–4463.
  • Syed YY. Pitolisant: first global approval. Drugs. 2016;76(13):1313–1318.
  • Lin JS, Dauvilliers Y, Arnulf I, et al. An inverse agonist of the histamine H(3) receptor improves wakefulness in narcolepsy: studies in orexin-/- mice and patients. Neurobiol Dis. 2008;30(1):74–83.
  • Dauvilliers Y, Bassetti C, Lammers GJ, et al. Pitolisant versus placebo or modafinil in patients with narcolepsy a double-blind, randomised trial. Lancet Neurol . 2013;12(11):1068–1075.
  • Szakacs Z, Dauvilliers Y, Mikhaylov V, et al. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(3):200–207.
  • Dauvilliers Y, Arnulf I, Szakacs Z, et al. Long -term use of pitolisant to treat patients with narcolepsy: harmony III Study. Sleep. 2019 21;42(11):zsz174.
  • Lehert P, Falissard B. Multiple treatment comparison in narcolepsy: a network meta-analysis. Sleep. 2018;41(12).
  • European Medicines Agency. Wakix (pitolisant): summary of product characteristics. [cited 2019 Oct 14]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/wakix
  • Ligneau X, Perrin D, Landais L, et al. BF2.649 [1-{3-[3-(4-Chlorophenyl)propoxy]propyl}piperidine, hydrochloride], a nonimidazole inverse agonist/antagonist at the human histamine H3 receptor: preclinical pharmacology. J Pharmacol Exp Ther. 2007;320:365–375.
  • Uguen M, Perrin D, Belliard S, et al. Preclinical evaluation of the abuse potential of Pitolisant, a histamine H₃ receptor inverse agonist/antagonist compared with Modafinil. Br J Pharmacol. 2013;169(3):632–634.
  • Huyts B, Brabant C, Tirelli E. Pitolisant and intravenous cocaine self-administration in mice. Eur J Pharmacol. 2019;851:63–68.
  • Brabant C, Charlier Y, Navacerrada MES, et al. Action of Pitolisant on the stimulant and rewarding effects of cocaine in mice. Eur J Pharmacol. 2016;791:552–559.
  • Setnik B, McDonnell M, Mills C, et al. Evaluation of the abuse potential of pitolisant, a selective H3-receptor antagonist/inverse agonist, for the treatment of adult patients with narcolepsy with or without cataplexy. Sleep. 2019 Oct 18. [Epub ahead of print].
  • Shah RR, Maison-Blanche P, Robert P, et al. Can an early phase clinical pharmacology study replace a thorough QT study? Experience with a novel H3-receptor antagonist/inverse agonist. Eur J Clin Pharmacol. 2016;72(5):533–543.
  • Scolnick B. Antihistamine agents and pitolisant might be useful for anorexia nervosa. Med Hypotheses. 2019 Jul 30;132:109342. [Epub ahead of print].
  • Kasteleijn-Nolst Trenité D, Parain D, Genton P, et al. Efficacy of the histamine 3 receptor (H3R) antagonist pitolisant (formerly known as tiprolisant; BF2.649) in epilepsy: dose-dependent effects in the human photosensitivity model. Epilepsy Behav. 2013;28(1):66.
  • Collart Dutilleul P, Ryvlin P, Kahane P, et al. Exploratory phase II trial to evaluate the safety and the antiepileptic effect of pitolisant (BF2.649) in refractory partial seizures, given as adjunctive treatment during 3 months. Clin Neuropharmacol. 2016;39(4):188–193.

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