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JAZZ

Jazz Pharmaceuticals

$151.00 /

-0.56 (-0.37%)

16:17
01/20/20
01/20
16:17
01/20/20
16:17

Jazz Pharmaceuticals receives EU Marketing Authorization for Sunosi

Jazz Pharmaceuticals announced that the European Commission approved Sunosi to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure. Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat EDS in adults living with narcolepsy or OSA and the only licensed therapy in the European Union for the treatment of EDS in adults living with OSA. Once-daily Sunosi is approved with doses of 75 mg and 150 mg for people with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for patients with OSA. At Week 12 of the Phase 3 clinical trial, 150 mg of solriamfetol for narcolepsy patients and both 75 mg and 150 mg doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed via the maintenance of wakefulness test from approximately one hour post-dose through approximately nine hours post-dose. The European Commission approval extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein. The Marketing Authorization Application for Sunosi is based on data from four randomized placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness clinical trial program. Data from the studies in the TONES program demonstrated the superiority of solriamfetol relative to placebo.

  • 29

    Jan

JAZZ Jazz Pharmaceuticals
$151.00 /

-0.56 (-0.37%)

01/08/20 Goldman Sachs
Jazz Pharmaceuticals initiated with a Neutral at Goldman Sachs
12/18/19 JMP Securities
JMP reiterates Outperform on Pfenex after Jazz milestone payment
12/05/19 JPMorgan
Jazz Pharmaceuticals shares offer attractive entry point, says JPMorgan
12/03/19 Wells Fargo
Jazz Pharmaceuticals price target raised to $186 from $168 at Wells Fargo

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