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 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIORESAL (baclofen) is a GABA-B receptor agonist that inhibits monosynaptic and polysynaptic reflexes at the spinal level to reduce muscle spasticity. Available in oral tablet form since 1977, it is used to treat spasticity associated with multiple sclerosis, spinal cord injury, and other neurological conditions. The drug works by decreasing excitatory neurotransmitter release and may also act at supraspinal sites.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), suggesting transition planning and potential downsizing of brand team resources.
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.