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Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Lumryz (sodium oxybate) is a sodium salt of GHB, a naturally occurring CNS depressant that increases dopamine levels and increases serotonin turnover. It is being developed for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.
Xywav (Calcium) is a lower-sodium oxybate approved by 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.
Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).
Axsome’s first-in-class DCC platform has been designed to optimize physician targeting and engagement, and promotional spend. The DCC platform and Axsome’s therapeutic focus will allow for increased reach to key Sunosi prescriber groups.
This FDA approval is based on the global Phase 3 double-blind, multicenter, placebo-controlled, randomized withdrawal study that demonstrated the efficacy and safety of Xywav for the treatment of idiopathic hypersomnia in adults.
Results from the Phase 3, placebo-controlled, double-blind, randomized withdrawal study of Xywav in adults with idiopathic hypersomnia including an oral presentation of the correlation of the idiopathic hypersomnia severity scale score with other measures of sleep parameters.
FT218 demonstrated statistically significant improvement in EDS at all evaluated doses in narcolepsy patients with or without stimulant use, with improvement over placebo on MWT and CGI-I.
REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.