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 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KEMSTRO is an orally disintegrating tablet formulation of baclofen, a small-molecule CNS depressant that inhibits monosynaptic and polysynaptic spinal reflexes. It is indicated for the treatment of skeletal muscle spasm resulting from rheumatic disorders. The drug works through spinal reflex inhibition, possibly via hyperpolarization of afferent terminals, though its complete mechanism of action remains incompletely understood.
LOE Approaching
Product is approaching end-of-life with moderate competitive pressure; brand teams should expect transition planning and resource reallocation within 2-3 years.
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.