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 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIORESAL (baclofen) is an oral small-molecule muscle relaxant and antispasticity agent approved in 1977 that works by inhibiting monosynaptic and polysynaptic reflexes at the spinal level, likely through GABA-B receptor stimulation. It is used to reduce muscle spasms and spasticity associated with conditions such as spinal cord injury, cerebral palsy, and multiple sclerosis. Baclofen decreases excitatory neurotransmitter release from primary afferent terminals, producing CNS depressant effects including sedation and muscle relaxation.
LOE Approaching
Product is in late-stage lifecycle with approaching loss of exclusivity; expect gradual team contraction and shift toward generic/lifecycle management strategies.
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.