Jazz Pharmaceuticals plc

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Products, Regulatory

Jazz Pharmaceuticals Announces Positive Top Line Results From Phase 3 Study Of Xywav Oral Solution In Adult Patients With Idiopathic Hypersomnia

Published: 10/08/2020 11:53 GMT
Jazz Pharmaceuticals PLC (JAZZ) - Jazz Pharmaceuticals Announces Positive Top-line Results From Phase 3 Study of Xywav™ (calcium, Magnesium, Potassium, and Sodium Oxybates) Oral Solution in Adult Patients With Idiopathic Hypersomnia.
Jazz Pharmaceuticals Plc - Clinically Meaningful and Highly Statistically Significant Results for Primary and Both Key Secondary Endpoints for Xywav.
Jazz Pharmaceuticals - U.S. FDA Grants Fast Track Designation to Xywav for Idiopathic Hypersomnia.
Jazz Pharmaceuticals - Safety Profile in Study Was Consistent With Known Safety Profile of Xywav With No New Safety Signals Observed.
Jazz Pharmaceuticals - Phase 3 Study Data Will Be Included in Planned Submission of Supplemental New Drug Application to FDA As Early As Q1 2021.