NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
3
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…
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
Loss of Exclusivity
LOE Date
Jun 10, 2029
39 months away
Patent Expiry
Jun 10, 2029
Company
R-Pharm US
NJ - Princeton