Is excessive sleepiness a disease?

Article source: Pharmaceutical Guanlan

Today (November 8), the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that the narcolepsy treatment drug tilolisant hydrochloride film-coated tablets (pitolisant, Wakix) introduced by Langhua Medicine has been submitted in China.

Screenshot source: CDE official website

Narcolepsy is a disabling neurological disorder in which patients cannot properly regulate the cycle of sleep and wakefulness, resulting in symptoms of drowsiness

According to public information, tilolixan is a "first-in-class" selective histamine 3 (H3) receptor antagonist/inverse agonist, which works through a new mechanism of action, that is, by enhancing the group.

According to the results of a post hoc analysis of data from two phase 3 clinical trials published in the journal Sleep Medicine in March 2021, the investigators' analysis of three independent subgroups of adults with narcolepsy showed that: on the Epworth Sleepiness Scale ( In patients with a high burden of excessive daytime sleepiness (EDS) as defined by the ESS) score, the mean change from baseline in ESS score was significantly greater in the tilolixan group compared with placebo (–6.

Headache was the most common adverse event observed with tislorisan in the study

According to public information, tilolixan was designed and developed by Bioprojet

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China.

[3] Harmony Biosciences Announces FDA Approval Of WAKIX® (Pitolisant), A First-In-Class Medication For The Treatment Of Excessive Daytime Sleepiness In Adult Patients With Narcolepsy.

[4]Harmony Biosciences Highlights Publication of WAKIX(pitolisant) Efficacy Data in Sleep Medicine.