NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
3
Data completeness
6/8 — Strong
HORIZANT (gabapentin enacarbil) by R-Pharm US is and, accordingly, its therapeutic effects in rls and phn are attributable to gabapentin. First approved in 2011.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HORIZANT is an extended-release oral formulation of gabapentin enacarbil, a prodrug of gabapentin approved in 2011 for restless legs syndrome (RLS) and postherpetic neuralgia (PHN). The drug's mechanism involves binding to the α2δ subunit of voltage-activated calcium channels, though the precise therapeutic pathway remains incompletely understood. It represents a structural analog of GABA engineered for improved bioavailability.
$0.033BPart D
LOE Approaching3.0 years to LOEProduct approaching LOE in 3 years with modest Part D spending ($33M annually); teams should anticipate transition to lifecycle management and generic competition planning.
Mechanism 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Started Mar 2017
375 enrolled
Restless Legs Syndrome (RLS)
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
Started Nov 2013
19 enrolled
Restless Legs Syndrome (RLS)
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Started Dec 2007
182 enrolled
Restless Legs Syndrome
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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.