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Pitolisant was approved by the FDA in August 2019. [10] [11] It was granted orphan drug designation for the treatment of narcolepsy, [24] fast track designation for the treatment of excessive daytime sleepiness and cataplexy in people with narcolepsy, and breakthrough therapy designation for the treatment of cataplexy in people with narcolepsy ...
In January 2017, the FDA approved the first generic sodium oxybate product for narcolepsy symptoms, which is also subject to the same REMS program conditions as the original. [60] By April 2017, seven companies had filed Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of Xyrem, which resulted in Jazz ...
A 2016 study by Leu-Semenescu et al. found sodium oxybate reduced daytime sleepiness in IH to the same degree as in patients with narcolepsy type 1, and the drug improved severe sleep inertia in 71% of the hypersomnia patients. [41] In July 2020, the FDA approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates), an oral solution ...
Axsome's other drug, Sunosi, is approved to improve wakefulness in adults with excessive sleepiness from either narcolepsy or sleep apnea. ... Around 70% of patients with narcolepsy also ...
The U.S. Food and Drug Administration (FDA) approved solriamfetol based primarily on evidence from five clinical trials (Trial 1/NCT02348593, Trial 2/NCT02348606, Trial 3/NCT02348619, Trial 4/NCT02348632, Trial 5 NCT01681121) of 622 patients with narcolepsy or obstructive sleep apnea (OSA). [16]
Xywav is a medication used to treat cataplexy or excessive daytime sleepiness. [ 2 ] [ 3 ] It contains a mixture of the oxybate salts calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate . [ 2 ]
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