- Health Canada has approved Jazz Pharmaceuticals plc's (NASDAQ: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.
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