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 10h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GABLOFEN is a baclofen injection administered intrathecally for the treatment of spasticity, working as a GABA-A agonist to reduce muscle tone. It represents a specialized injectable formulation of baclofen for patients requiring direct spinal delivery. The drug targets severe spasticity unresponsive to oral therapies.
$0.108MPart D
LOE ApproachingLOE-approaching status signals declining commercial resources and team contraction; focus shifts to managed decline and existing patient retention.
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
GABLOFEN offers limited career momentum given its LOE-approaching status and minimal linked job postings; however, roles focus on managed decline, payer negotiations, and patient support. Professionals should expect contracting team size and transition opportunities to other pipeline assets.
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.