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Find Drugs for Sleep in Phase III Clinical Development
Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
BF2.649 (pitolisant hydrochloride) is an antagonist/inverse agonist that binds to the histamine H3 receptor, an autoreceptor located in the presynaptic region of the histamine-containing neurons in the human brain that plays a critical role in regulating sleep and wake rhythm.
LUMRYZ is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once-at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
HETLIOZ® (Tasimelteon), is a melatonin receptor agonist and the first and only medication that's been proven to treat people with Non-24 and nighttime sleep disturbances in SMS.
LUMRYZ is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of EDS or cataplexy in adults with narcolepsy.
WAKIX® (pitolisant) Tablets, a first-in-class medication, is a selective histamine 3 (H3) receptor antagonist/inverse agonist, is approved by U.S.FDA for treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.
Presentation highlights results from a questionnaire assessing patient preference for once-nightly versus twice-nightly dosing regimen and another questionnaire assessing experiences with the second nightly dose in patients who switched from twice-nightly oxybates to FT218.
Post-hoc analyses support positive results observed in completed Phase 3 REST-ON trial and demonstrated improvement in subjective measures of daytime sleepiness, sleep quality and refreshing nature of sleep with once-at-bedtime FT218 as early as week 1.
FT218, also known as ON-SXB is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
The placebo-controlled studies investigated the effects of three doses of daridorexant (10 mg, 25 mg, and 50 mg) on sleep and daytime functioning parameters, objectively in a sleep lab by polysomnography and subjectively with a daily patient diary at home.