LIORESAL
LOE ApproachingNDAORALTABLETPriority Review
Approved
Nov 1977
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
LIORESAL by Novartis is clinical pharmacology the precise mechanism of action of baclofen as a muscle relaxant and antispasticity agent is not fully understood. First approved in 1977.
Drug data last refreshed 4d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIORESAL (baclofen) is a small-molecule GABA-B receptor agonist used to treat muscle spasticity and related hyperreflexia conditions. It works by inhibiting monosynaptic and polysynaptic reflexes at the spinal level, reducing excitatory neurotransmitter release and CNS activity. The drug is available in oral tablet form and as an intrathecal injection for severe cases requiring direct delivery to cerebrospinal fluid.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure, the brand team is likely focused on lifecycle extension and cost management rather than growth acceleration.
Mechanism of Action
CLINICAL PHARMACOLOGY The precise mechanism of action of baclofen as a muscle relaxant and antispasticity agent is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary…
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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.