NDAORALGRANULES
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
15
Data completeness
7/8 — Comprehensive
LYVISPAH (baclofen) by PharmaIN is gaba a agonists [moa]. Approved for spasticity. First approved in 2021.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYVISPAH (baclofen) is an oral granule formulation of the GABA-A agonist baclofen, approved in November 2021 for spasticity, neuropathic pain, and off-label use in alcohol use disorder and select hematologic malignancies. It works by enhancing inhibitory neurotransmission in the central nervous system to reduce muscle tone and pain signaling.
$0.144BPart D
Peak15.4 years to LOEProduct is in peak lifecycle stage with minimal Medicare Part D volume ($144K in 2023), indicating niche positioning with limited commercial team expansion.
Mechanism of Action
GABA A Agonists
Pharmacologic Class:
gamma-Aminobutyric Acid-ergic Agonist
Indications (1)
Clinical Trials (15)
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
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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.