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Narcolepsy

Neurologyยท 4 reviewed drugsยท 2482 cited findings behind them

What the regulatory reviews cover

Regulatory review documents for several drugs indicated for narcolepsy are available in this library. These include Wakix, Xyrem, Pitolisant, and JZP-258. The reviews detail various efficacy and safety outcomes observed in clinical trials.

For example, Wakix demonstrated a UNS total score difference (pitolisant minus placebo) of -3.69 (1.37) [-6.38; -0.99]. Xyrem showed a median change from baseline in weekly cataplexy attacks (Xyrem arm, final analysis) of 0.27, compared to 12.71 in the placebo arm. Pitolisant achieved a mean ESS score reduction from baseline of -4.6. JZP-258 resulted in a mean change in weekly cataplexy attacks of 0.12, versus 11.46 for placebo. It is important to note that these figures are derived from different studies and are not directly comparable head-to-head.

The drugs โ€” one cited result each

Wakix

Bioprojet

UNS total score difference (pitolisant minus placebo): -3.69 (1.37) [-6.38; -0.99]

Bioprojet โ€” Wakix EMA EPAR variation assessment report (EMEA, p.32

Xyrem

Jazz Pharmaceuticals plc

Median change from baseline in weekly cataplexy attacks (Xyrem arm, final analysis): 0.27

JAZZ PHARMS โ€” Xyrem FDA Review, p.349

Pitolisant

Bioprojet

Mean ESS score reduction from baseline (pitolisant): -4.6

Bioprojet โ€” Wakix EMA EPAR public assessment report (EMEA/H/, p.54

JZP-258

Jazz Pharmaceuticals plc

Mean change in weekly cataplexy attacks (JZP-258): 0.12

Xywav FDA Review, p.6

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Neurology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Narcolepsy โ€” 4 Drugs, FDA & EMA Review Findings | BioPharmaPT Neurology