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     116  0 Kommentare Jazz Pharmaceuticals Announces Xywav (calcium, magnesium, potassium, and sodium oxybates) Investor Webcast on October 13, 2021

    DUBLIN, Sept. 13, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will host a webcast on Wednesday, October 13, 2021 at 4:30 p.m. ET / 9:30 p.m. IST to provide an update on Xywav (calcium, magnesium, potassium and sodium oxybates), the first and only U.S. Food and Drug Administration-approved treatment for idiopathic hypersomnia (IH) in adults, which was approved on August 12, 2021.

    Jazz senior management will provide an overview of Xywav and commercial launch plans in IH, and Richard Bogan, M.D., FCCP, FAASM, president of Bogan Sleep Consultants, LLC and associate clinical professor, University of South Carolina School of Medicine and Medical University of South Carolina, Charleston, S.C., will discuss IH.

    Audio webcast/conference call:
    U.S. Dial-In Number: +1 (855) 353-7924
    International Dial-In Number: +1 (503) 343-6056
    Passcode: 2789509

    The live webcast may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. A replay of the webcast will be archived on the website for at least one week.  

    Replay U.S. Dial-In Number: +1 (855) 859-2056
    Replay International Dial-In Number: +1 (404) 537-3406
    Passcode: 2789509

    About Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution
    Xywav
    , also known as JZP258, is a lower-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy and for the treatment of idiopathic hypersomnia in adults. In June 2021, the FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy by means of greater safety compared to Xyrem (sodium oxybate). The decision of the OOPD is based on FDA findings that Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. There are no head-to-head data for Xywav and Xyrem. Xywav is comprised of a unique composition of cations resulting in 92 percent less sodium, or a reduction of approximately 1,000 to 1,500 mg/night, than sodium oxybate at the recommended adult dosage range of 6 to 9 grams. While the exact mechanism of action of Xywav is unknown, it is hypothesized that the therapeutic effects of Xywav on cataplexy and excessive daytime sleepiness are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons. The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.

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    Jazz Pharmaceuticals Announces Xywav (calcium, magnesium, potassium, and sodium oxybates) Investor Webcast on October 13, 2021 DUBLIN, Sept. 13, 2021 /PRNewswire/ - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will host a webcast on Wednesday, October 13, 2021 at 4:30 p.m. ET / 9:30 p.m. IST to provide an update on Xywav (calcium, magnesium, …