Safety and tolerability of pitolisant in the treatment of adults with narcolepsy: integrated data from clinical studies

Scart-Grès, Catherine; Momah, C.; Roy, Manju; Maski, Kiran; Piris, S.; Bogan, Richard

doi:10.1016/j.sleep.2019.11.738

Cited by 2 publications

(3 citation statements)

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“…An integrated safety analysis of pooled data from four short-term (7-to 8-week) pitolisant randomised controlled trials that used flexible dosing up to 35.6 mg (three studies) or 17.8 mg (one study) evaluated AEs, vital signs, laboratory assessments and electrocardiogram (ECG) data [21]. The analysis population included 303 participants (pitolisant, n = 172; placebo, n = 131).…”

Section: Safety/tolerabilitymentioning

confidence: 99%

Recently Approved and Upcoming Treatments for Narcolepsy

Thorpy

2020

CNS Drugs

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Narcolepsy is a chronic, disabling neurologic disorder characterised by excessive daytime sleepiness (EDS) and, in up to 60% of patients, cataplexy. Treatments for narcolepsy are aimed at improving wakefulness (e.g. modafinil, armodafinil, stimulants), reducing cataplexy attacks (e.g. sodium oxybate, venlafaxine), and treating the symptoms of disturbed nocturnal sleep, sleep paralysis and sleep-related hallucinations (e.g. sodium oxybate). In general, medications that increase the release, or inhibit the reuptake, of norepinephrine or dopamine have wake-promoting effects and are useful in managing EDS, whereas medications that inhibit serotonin or norepinephrine reuptake have anticataplectic effects. Modulation of γ-aminobutyric acid B (GABA B) receptors or histamine H 3 receptors (H3Rs) has effects on both EDS and cataplexy. Pitolisant, an H3R antagonist, and solriamfetol, a dopamine and norepinephrine reuptake inhibitor, are the most recently approved treatments for EDS associated with narcolepsy in the European Union (pitolisant) and the USA (pitolisant and solriamfetol). Several new agents are being developed and tested as potential treatments for EDS and cataplexy associated with narcolepsy; these agents include novel oxybate formulations (once-nightly [FT218]; low sodium [JZP-258]), a selective norepinephrine reuptake inhibitor (AXS-12), and a product combining modafinil and an astroglial connexin inhibitor (THN102). This review summarises the mechanisms of action, pharmacokinetics, efficacy, and safety/tolerability of recently approved and emerging treatments for narcolepsy. Key Points Excessive daytime sleepiness and cataplexy are common and disabling symptoms associated with narcolepsy. Emerging treatments, including two recently approved medications (pitolisant and solriamfetol) and several medications still in development (FT218, JZP-258, AXS-12, THN102, SUVN-G3031, TAK-925), provide new options for the treatment of narcolepsy.

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Section: Safety/tolerabilitymentioning

confidence: 99%

Recently Approved and Upcoming Treatments for Narcolepsy

Thorpy

2020

CNS Drugs

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“…study et al, and included headaches (11.8%), insomnia (8.8%) and nausea (4.9%). 55 Harmony 3 also reported weight gain (7.8%), anxiety (6.9%) and depression (4.9%). 52 Drug-drug interaction studies have shown that CYP3A4 inducers reduce pitolisant exposure, and CYP2D6 inhibitors increase pitolisant levels.…”

Section: Pitolisantmentioning

confidence: 98%

“…52 Changes in vital signs, laboratory tests and ECG parameters attributable to pitolisant were not seen. 55 In the abovementioned Harmony 3 study, 57% of participants treated with pitolisant reported TEAEs, the majority of which (55%) occurred during the first 3 months. 52 A higher rate of TEAEs was seen in patients who were receiving concomitant narcolepsy treatment.…”

Section: Pitolisantmentioning

confidence: 99%

Pharmacologic Therapy for Narcolepsy

Ishikawa¹,

Hahn²,

Greenberg³

2022

Neurology

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Narcolepsy is a lifelong disorder that adversely affects daytime function and quality of life. Major symptoms include excessive daytime sleepiness with irrepressible sleep attacks and cataplexy. Recent developments in the understanding of the pathobiology of narcolepsy, as well as the neuronal systems involved in the regulation of wakefulness have led to development of new pharmacologic approaches to therapy. In this paper, we review available pharmacologic treatments for narcolepsy as well as agents currently under investigation.

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Safety and tolerability of pitolisant in the treatment of adults with narcolepsy: integrated data from clinical studies

Cited by 2 publications

References 0 publications

Recently Approved and Upcoming Treatments for Narcolepsy

Recently Approved and Upcoming Treatments for Narcolepsy

Pharmacologic Therapy for Narcolepsy

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