NDAINTRATHECALINJECTABLE
Approved
Nov 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
GABLOFEN (baclofen injection) by Piramal Pharma is gaba a agonists [moa]. First approved in 2010.
Drug data last refreshed 8h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GABLOFEN is an intrathecal baclofen injection approved in 2010 for the treatment of spasticity. It works as a GABA-A agonist, enhancing inhibitory neurotransmission in the central nervous system to reduce muscle tone and involuntary muscle contractions. This is a small-molecule injectable delivered directly into the cerebrospinal fluid via implanted pump systems.
$0.108MPart D
LOE ApproachingDeclining
Declining revenue and low claim volume indicate a mature product with limited growth opportunity; brand team likely operating in steady-state or maintenance mode.
Mechanism of Action
GABA A Agonists
Pharmacologic Class:
gamma-Aminobutyric Acid-ergic Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump
Started Dec 2012
153 enrolled
Severe Spasticity
Career Relevance
Working on GABLOFEN offers limited career upside given its LOE-approaching status and declining commercial trajectory. Roles on this product focus on defending market share, optimizing margins, and managing generic transition rather than launching or scaling a growth brand.
Brand Manager
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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.