[{"orgOrder":0,"company":"Jazz Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Jazz Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia's Rival to Merck's Insomnia Drug Clears Phase 3 Test","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218 ","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces First Patient Dosed in Open-Label Extension\/Switch Study of Investigational Once-Nightly FT218","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Second PhIII Study for Idorsia's Sleep Drug Returns Positive Results","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Daridorexant Phase 3 Results In Insomnia to be Presented at Sleep 2020","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase 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Completes Capital Increase with Gross Proceeds of CHF 535.5 Million","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia to Present New Phase 3 Data on Daridorexant in Insomnia at Sleep 2021","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Presents New Data Supporting Clinical Benefit with Once-at-Bedtime FT218 and Preference for Once-Nightly Dosing in Patients with Narcolepsy at CHEST 2021","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Announces New Positive Data for Once-at-Bedtime FT218 for Narcolepsy and Once-Nightly Dosing Preference Among Patients and Clinicians at World Sleep 2022","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Interim Data from the Open-Label RESTORE Study at the 2022 American Academy of Neurology Annual Meeting","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Harmony Biosciences Initiates Phase 3 Trial of Pitolisant in Adult Patients With Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Harmony Biosciences"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Tentative Approval of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vanda Pharmaceuticals Announces Notice Of Opportunity For An Fda Hearing On The Snda For Hetlioz\u00ae In Jet Lag Disorder","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Vanda Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Favorable Ruling on Motion to Delist REMS Patent from FDA\u2019s Orange Book","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Publication of Real-World Data Highlighting the Risk of Accidental Dosing Errors with Immediate-Release Twice-Nightly Oxybates","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Aculys Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aculys Pharma Initiates Phase 3 Trial of Pitolisant Treating Patients with Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea Syndrome","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Aculys Pharma"}]
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.
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