Canada Approves Jazz Pharma's Excessive Daytime Sleepiness Med

Health Canada has approved Jazz Pharmaceuticals plc's JAZZ Sunosi (solriamfetol) for excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA) in adult patients.
Once-daily Sunosi is approved with doses of 75 mg and 150 mg.
Sunosi is the first dopamine and norepinephrine reuptake inhibitor (DNRI).
The approval is based on four Phase 3 trials in over 1,500 adults.
Data from the studies demonstrated the superiority of solriamfetol relative to placebo.
Up to 78% of the narcolepsy patients and up to 90% of the OSA patients taking 150 mg reported feeling better as measured by the Patient Global Impression of Change (PGIc) scale.
The efficacy of Sunosi was maintained for at least six months in a follow-up study (TONES 5).
Related content: Benzinga's Full FDA Calendar.
Price Action: JAZZ shares are up 0.15% at $131.73 during the market session on the last check Tuesday.