NDAINTRATHECALINJECTABLEPriority Review
Approved
Jun 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
4/8 — Partial
Priority Review
LIORESAL (baclofen) by Novartis is gaba a agonists [moa]. First approved in 1992.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIORESAL (baclofen) is a GABA-A agonist administered intrathecally for management of severe spasticity. It works by enhancing inhibitory neurotransmission in the spinal cord, reducing muscle tone and involuntary contractions. The product is delivered via intrathecal pump, representing a specialized delivery mechanism requiring patient monitoring and refill procedures.
LOE Approaching
As LOE approaches, brand teams face declining market share and shifting focus toward retention, requiring defensive strategies and potential workforce restructuring.
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 (16)
Intrathecal Baclofen and Pediatric Dystonia
Started Nov 2024
65 enrolled
Dystonic Cerebral Palsy
A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers
Started Jan 2017
40 enrolled
Healthy Volunteers
Intrathecal (IT) Baclofen Drug Distribution
Started Apr 2016
27 enrolled
Muscle Spasticity
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
Started Sep 2015
18 enrolled
Alcohol Use Disorder
Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.
Started Dec 2014
12 enrolled
Neuropathic Pain
Worked on LIORESAL at Novartis? Share your interview experience or compensation data (+7 days Pro)
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.