KEMSTRO
LOE ApproachingNDAORALTABLET, ORALLY DISINTEGRATING
Approved
Oct 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
KEMSTRO by UCB Pharma is clinical pharmacology the precise mechanism of action of baclofen is not fully known. Approved for the treatment of skeletal muscle spasm resulting from rheumatic disorders. First approved in 2003.
Drug data last refreshed 3d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KEMSTRO is an orally disintegrating tablet formulation of baclofen, a GABA analog that inhibits monosynaptic and polysynaptic reflexes at the spinal level. It is indicated for spasticity associated with multiple sclerosis. The drug's precise mechanism remains incompletely understood, though it likely works through CNS depression and spinal reflex modulation.
LOE Approaching
Product approaching loss of exclusivity with limited current job activity; commercial teams likely focused on lifecycle extension strategies or managed decline.
Mechanism of Action
Clinical Pharmacology The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and…
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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.