NDAORALSUSPENSION
Approved
Feb 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
15
Data completeness
7/8 — Comprehensive
FLEQSUVY (baclofen) by R-Pharm US is gaba a agonists [moa]. Approved for spasticity. First approved in 2022.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLEQSUVY is an oral baclofen suspension approved in 2022 that acts as a GABA-A agonist to reduce muscle spasticity and treat neuropathic pain. It is indicated for spasticity associated with cerebral palsy, muscle spasticity, neuropathic pain, and emerging evidence suggests potential use in alcohol use disorder and cocaine-related disorders. The drug works by enhancing inhibitory GABAergic neurotransmission in the central nervous system.
$0.831MPart D
Peak11.4 years to LOEEarly-stage peak product with modest Medicare uptake (398 claims in 2023) suggests a small, specialized sales force focused on neurology and pain specialists.
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
Worked on FLEQSUVY at R-Pharm US? 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.