NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
3
Data completeness
7/8 — Comprehensive
HORIZANT (gabapentin enacarbil) by R-Pharm US is and, accordingly, its therapeutic effects in rls and phn are attributable to gabapentin. Approved for restless legs syndrome. First approved in 2011.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HORIZANT (gabapentin enacarbil) is an extended-release oral tablet approved in 2011 for moderate-to-severe primary restless legs syndrome (RLS) and postherpetic neuralgia (PHN) in adults. It is a prodrug of gabapentin that binds with high affinity to the α2δ subunit of voltage-activated calcium channels, though the precise mechanism of therapeutic efficacy remains unknown. The drug prevents allodynia and hyperalgesia in neuropathic pain models and addresses unmet needs in two distinct chronic conditions with significant patient populations.
$0.0BPart D
3.1 years to LOEMechanism of Action
and, accordingly, its therapeutic effects in RLS and PHN are attributable to gabapentin. The precise mechanism by which gabapentin is efficacious in RLS and PHN is unknown. The mechanism of action by which gabapentin is efficacious in PHN is unknown but in animal models of analgesia, gabapentin…
Indications (1)
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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.