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

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

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  • 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

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Kbm-hogue


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