Cns Drugs
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Oral gabapentin enacarbil is approved in adult patients for the treatment of moderate to severe primary restless legs syndrome (RLS) [featured indication] and the management of postherpetic neuralgia. In the 12-week Patient Improvements in Vital Outcomes following Treatment (PIVOT) RLS I and II trials in adult patients with moderate to severe primary RLS (n > 500 total evaluable), once-daily gabapentin enacarbil 600 or 1,200 mg significantly improved mean International Restless Legs Scale (IRLS) total scores compared with placebo, with significantly higher investigator-rated Clinical Global Impression-Improvement (CGI-I) responder rates in gabapentin enacarbil groups than in placebo groups. Improvements in other sleep outcomes (assessed using various scales) also generally favoured gabapentin enacarbil treatment. ⋯ Gabapentin enacarbil was generally well tolerated in adult patients with RLS participating in short- and longer-term clinical trials. The most common treatment-emergent adverse events were somnolence/sedation and dizziness. Most adverse events were of mild to moderate severity, with relatively few patients discontinuing treatment because of an adverse event.
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Perampanel is a novel antiepileptic drug (AED) used as adjunctive therapy in adolescents and adults with partial-onset seizures (with or without secondarily generalized seizures). It is a selective, noncompetitive antagonist of α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)-type glutamate receptors on post-synaptic neurons, and is the first in this new class of AED known as AMPA receptor antagonists. In three randomized, double-blind, placebo-controlled, phase III trials in adolescent and adult patients with refractory partial-onset seizures, once-daily administration of perampanel 4, 8 and 12 mg/day (6-week titration phase followed by 13-week maintenance phase), as adjunctive therapy with one to three AEDs, was statistically superior to adjunctive placebo in achieving the key efficacy endpoints of the median percentage change from baseline in seizure frequency and/or the proportion of patients with a ≥50 % reduction in seizure frequency relative to baseline. ⋯ Interim data from a large extension study (16-week blinded conversion period followed by open-label maintenance phase), which enrolled patients who completed the phase III trials, showed a similar group response for the reduction in seizure frequency over at least 1 year of adjunctive treatment with perampanel. Perampanel was generally well tolerated over the longer-term in extension studies, with no unexpected adverse events reported. On the basis of its overall clinical profile and unique mechanism of action, perampanel is a useful adjunctive treatment option in patients with refractory partial-onset seizures.