Jazz Pharmaceuticals’ Sunosi (solriamfetol) Receives EMA’s MAA for Excessive Daytime Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea

Shots:

• The MAA is based on four studies included in TONES program assessing Sunosi (75mg/150mg or 37.5mg, 75mg and 150 mg) vs PBO in 900+ adults with EDS associated with narcolepsy or OSA respectively
• TONES 2 & 3 studies result: @12wks. improvement in their overall clinical condition as assessed by PGIc scale (68-74% @75mg & 78-90% @150mg) respectively; improvement in wakefulness
• Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor and has received the US FDA’s approval on Mar 20, 2019 to improve wakefulness, designated as Schedule IV medicine by the US Drug Enforcement Agency on Jun 17, 2019

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