NDAORALFOR SUSPENSION, EXTENDED RELEASE
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
6/8 — Strong
LUMRYZ (sodium oxybate) by Ascentage Pharma is 12. First approved in 2023.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUMRYZ (sodium oxybate) is an extended-release oral suspension CNS depressant approved in May 2023 for narcolepsy. The mechanism of action is not fully understood but is hypothesized to involve GABA-B mediated effects on noradrenergic, dopaminergic, and thalamocortical neurons. It is the first and only extended-release formulation of sodium oxybate, differentiating it from immediate-release competitors.
$0.002BPart D
Peak15.5 years to LOEEarly-stage peak product with minimal claims volume suggests significant growth opportunity and expanding commercial infrastructure needs.
Mechanism of Action
12.1 Mechanism of Action LUMRYZ is a CNS depressant. The mechanism of action of LUMRYZ in the treatment of narcolepsy is unknown. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the…
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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.