'The Sunosi acquisition marks the transformation of Axsome into a commercial neuroscience company and reflects our commitment to the millions of people living with serious neurologic and psychiatric conditions.'
Jazz announced on Monday that the U.S. Food and Drug Administration granted them Orphan Drug Exclusivity for the medication Xywav for the treatment of idiopathic hypersomnia.
A common concern in narcolepsy and idiopathic hypersomnia is a feeling of having little control over symptoms, which can lead to despair. But disorders of excessive sleepiness do have both medication and non-medication treatment approaches.
It’s been an unusual year. But, mostly as usual, the US Food & Drug Administration continued to review device and drug applications across all fields of medicine.
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A literature review from Stanford University looks at how the popular narcolepsy medication sodium oxybate impacts heart health.
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Results of the double-blind, placebo-controlled, randomized-withdrawal, multicenter study were previously presented at World Sleep 2019.
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“There is significant need for greater awareness of idiopathic hypersomnia, which can severely impact a person’s daily life, and can often be misdiagnosed or undiagnosed over a substantial period of time.”
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With financial support from Jazz Pharmaceuticals, the American Heart Association will create sleep-related educational multimedia content.
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The FDA approved a new oxybate formulation for excessive daytime sleepiness or cataplexy in narcolepsy. Should your patients switch?
Read MoreHighlights include presentations on Xywav, a lower sodium oxybate iindicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
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Marketed by Jazz Pharmaceuticals, Xywav is for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
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Sleep professionals and the general public have misperceptions about the neurological sleep disorder. How many did you believe?
Read MoreSleep Review annually rounds up the sleep medicine devices, pharmaceuticals, and more that earned US Food and Drug Administration clearance.
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The FDA accepted for filing with Priority Review the Jazz Pharmaceuticals plc’s NDA seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
Read MoreSolriamfetol, a dopamine and norepinephrine reuptake inhibitor, offers short-term improvements in health-related quality of life (HRQoL), and work productivity in people with narcolepsy, according to study results published in Sleep Medicine.
Read MoreJazz Pharmaceuticals plc submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on January 21, 2020, seeking marketing approval for JZP-258, an investigational medicine for the treatment of...
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Investigators surveyed health care providers as well as people with narcolepsy, and multiple...
Read MoreThe European Commission has approved Jazz Pharmaceuticals plc’s Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or...
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