(N = 163)
% HORIZANT
1,200 mg/dayc
(N = 269)
%
Nervous system disorders
Somnolence/sedation 6 20 27
Dizziness 4 13 22
Headache 11 12 15
Gastrointestinal disorders
Nausea 5 6 7
Dry mouth 2 3 4
Flatulence <1 3 2
General disorders and administration site conditions
Fatigue 4 6 7
Irritability 1 4 4
Feeling drunk 0 1 3
Feeling abnormal <1 <1 3
Peripheral edema 1 <1 3
Metabolism and nutritional disorders
Weight increased 2 2 3
Increased appetite <1 2 2
Ear and labyrinth disorders
Vertigo 0 1 3
Psychiatric disorders
Depression <1 <1 3
Libido decreased <1 <1 2
a Placebo was a treatment arm in each of the 3 double-blind, placebo-controlled, 12-week clinical trials.
b The 600-mg dose of HORIZANT was a treatment arm in 2 of the 3 double-blind, placebo-controlled, 12-week clinical trials.
c The 1,200-mg dose of HORIZANT was a treatment arm in each of the 3 double-blind, placebo-controlled, 12-week clinical trials.
Adverse reactions reported in these three 12 week studies in <2% of patients treated with 600 mg of HORIZANT and numerically greater than placebo were balance disorder, blurred vision, disorientation, feeling drunk, lethargy, and vertigo.
The following adverse reactions were dose-related: somnolence/sedation, dizziness, feeling drunk, libido decreased, depression, headache, peripheral edema, and vertigo.
Postherpetic Neuralgia: The exposure to HORIZANT in 417 patients with PHN included 207 patients exposed for at least 3 months. Overall, the mean age of patients in the PHN studies ranged from 61 to 64 years of age across dose groups; the majority of patients were male (45% to 61%) and Caucasian (80% to 98%).
The safety of HORIZANT in doses ranging from 1,200 to 3,600 mg has been eva luated in 417 patients with PHN in 3 clinical studies. The principal efficacy study eva luating the efficacy and safety of HORIZANT in the management of PHN was a 12-week, double-blind, multicenter study comparing 1,200 mg/day, 2,400 mg/day and 3,600 mg/day to placebo. Six out of 107 (6%) patients treated with 1,200 mg of HORIZANT discontinued treatment due to adverse events compared with 12 of the 95 (13%) patients who received placebo.
The most commonly observed adverse reactions (≥10% and greater than placebo) in this trial for the 1,200 mg dose of HORIZANT were dizziness, somnolence, and headache (see Table 5). Table 5 lists treatment-emergent adverse reactions that occurred in ≥2% of patients with PHN treated with HORIZANT 1,200 mg/day and numerically greater than placebo.
Table 5. Incidence of Adverse Reactions (in At Least 2% of Patients Treated With 1,200 mg/day of HORIZANT and Numerically Greater Than the Placebo Rate) Reported in All Patients in the 12-Week PHN Study Body System/Adverse Reaction Placebo
(N = 95)
% HORIZANT
1,200 mg/day
(N = 107)
% HORIZANT
2,400 mg/day
(N = 82)
% HORIZANT
3,600 mg/day
(N = 87)
%
Nervous System & |
