Benzinga | Aug 31, 2021 11:47AM EDT

Canada Approves Jazz Pharma's Excessive Daytime Sleepiness Med

* 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.