Phase 3 Data Published for Once-Nightly OSA Drug Candidate AD109
Results from the SynAIRgy trial show the investigational oral therapy AD109 significantly reduced airway obstruction and improved oxygenation in patients with obstructive sleep apnea.
Tag: Phase 3
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First Orexin Agonist in Phase 3 Trials for Narcolepsy
A phase 3 readout is anticipated later this year.
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Avadel Presents Data from Phase 3 Trial Supporting Clinical Benefit of FT218 in Patients with Narcolepsy
“The new data analyses showing that FT218 improved excessive daytime sleepiness in patients with narcolepsy, both with and without cataplexy, regardless of stimulant use, are important for this patient population.”
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Jazz Pharmaceuticals Presents Phase 3 Results of Xywav in Idiopathic Hypersomnia
The AAN presentation further quantifies the previously reported Phase 3 top-line results.
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Avadel Presents New Data from Phase 3 Trial of Once-Nightly Sodium Oxybate
“The positive results previously disclosed from the REST-ON trial, regarding the three co-primary endpoints, are further bolstered by the secondary endpoints presented at AAN.”
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Xywav Phase 3 Data Published in SLEEP
Results of the double-blind, placebo-controlled, randomized-withdrawal, multicenter study were previously presented at World Sleep 2019.
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FDA Fast Tracks Xywav for Idiopathic Hypersomnia
“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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Xywav or Xyrem: What’s the Difference?
The FDA approved a new oxybate formulation for excessive daytime sleepiness or cataplexy in narcolepsy. Should your patients switch?
Read MoreInvestigational Insomnia Drug Improves Daytime Functioning in Phase 3 Study
A new patient-reported outcome instrument was developed to assess daytime functioning in patients with insomnia and Idorsia included it in daridorexant’s Phase 3 program.
Read MoreAvadel Shares Additional Data from Phase 3 Trial of Potential Narcolepsy Drug
“We are at a pivotal point in Avadel’s transformation, as we recently completed our pre-NDA meeting with the FDA and are currently focused on completing our NDA submission and filing for FT218.”
Read MorePhase 3 Study Results of Investigational Dual Orexin Receptor Antagonist for Insomnia to Be Presented at SLEEP 2020
Idorsia Ltd reports positive results from the first pivotal Phase 3 study investigating 25 and 50 mg doses of its dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia.
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