1Cademy - Recently approved Treatments for Narcolepsy: Pitolisant

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Recently approved Treatments for Narcolepsy: Pitolisant

First-in-class H3R antagonist/inverse agonist with wake-promoting and anticataplectic effects.
Approved in the EU and the US for narcolepsy treatment.
Dose range: 4.5–36 mg/day (EU), 17.8–35.6 mg/day (US).
Mechanism of Action: Acts on histaminergic neurons in the brain, enhancing histamine release.
PK/DDI: Rapid absorption, median tmax 3.5 h, metabolized by CYP3A4 and CYP2D6, affected by renal and hepatic impairment.
Efficacy: Improved ESS scores, MWT sleep latency, cataplexy frequency reduction.
Safety: Common AEs include insomnia, headache, nausea; potential for CYP interactions and QTc prolongation.

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Updated 2023-08-24

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