NDAORALSUSPENSION
Approved
Feb 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16
Data completeness
6/8 — Strong
FLEQSUVY (baclofen) by R-Pharm US is gaba a agonists [moa]. First approved in 2022.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLEQSUVY is an oral suspension formulation of baclofen, a GABA-A agonist approved in February 2022 for muscle spasticity and related conditions. The drug works by enhancing inhibitory neurotransmission in the central nervous system, reducing muscle tone and associated pain. This is a reformulation of an existing active pharmaceutical ingredient into a more patient-friendly suspension delivery.
$0.831MPart D
Peak11.0 years to LOEProduct is in peak lifecycle phase with modest Medicare Part D adoption; commercial team likely managing established market penetration with stable to modest growth expectations.
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
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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.