NDAORALSOLUTIONPriority Review
Approved
Jul 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYWAV is an oral solution containing calcium, magnesium, potassium, and sodium oxybates approved by the FDA on July 21, 2020. It is indicated for the treatment of narcolepsy, a chronic neurological disorder characterized by excessive daytime sleepiness and cataplexy. The product represents a reformulated version of sodium oxybate (Xyrem) designed to reduce sodium intake while maintaining therapeutic efficacy. XYWAV is positioned as a first-line treatment for narcolepsy and addresses a significant unmet need in a patient population with limited therapeutic options.
$0.2BPart D
14.8 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
Started Jul 2023
207 enrolled
Idiopathic HypersomniaNarcolepsy
A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Started Jun 2023
155 enrolled
Narcolepsy
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
Started Apr 2021
110 enrolled
Narcolepsy
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
Started Mar 2021
62 enrolled
Narcolepsy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.