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 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GABLOFEN is a baclofen injection administered intrathecally to treat muscle spasticity and related movement disorders through GABA-A agonism in the central nervous system. It reduces abnormal muscle tone by enhancing inhibitory neurotransmission in the spinal cord. The product targets patients with severe spasticity unresponsive to oral medications.
$0.108MPart D
LOE ApproachingStable
With LOE approaching and minimal Part D spending ($108K, 90 claims in 2023), the product team is likely small and focused on maintaining existing patient relationships rather than aggressive growth initiatives.
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 growth opportunities given its LOE-approaching status, minimal commercial spending ($108K annual Part D), and small patient population (90 claims in 2023). Roles on this product typically involve specialty pharmaceutical expertise in neurology and device-drug integration rather than large-scale commercial operations.
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.