led clinical trials (Studies 1, 2, and 3) of the adverse reactions that occurred in ≥2% of patients with partial-onset seizures in the FYCOMPA 12 mg dose group and more frequent than placebo (in order of decreasing frequency for the 12 mg dose group).
The most common dose-related adverse reactions in patients receiving FYCOMPA at doses of 8 mg or 12 mg (≥4% and occurring at least 1% higher than the placebo group) included dizziness (36%), somnolence (16%), fatigue (10%), irritability (9%), falls (7%), nausea (7%), ataxia (5%), balance disorder (4%), gait disturbance (4%), vertigo (4%), and weight gain (4%). For almost every adverse reaction, rates were higher on 12 mg and more often led to dose reduction or discontinuation.
Table 2. Adverse Reactions in Pooled Placebo-Controlled Trials in Patients with Partial-Onset Seizures (Studies 1, 2, and 3) (Reactions ≥ 2% of Patients in Highest FYCOMPA Dose (12 mg) Group and More Frequent than Placebo)
Placebo n=442
% FYCOMPA
4 mg
n=172
% 8 mg
n=431
% 12 mg
n=255
%
Dizziness 9 16 32 43
Somnolence 7 9 16 18
Headache 11 11 11 13
Irritability 3 4 7 12
Fatigue 5 8 8 12
Falls 3 2 5 10
Ataxia 0 1 3 8
Nausea 5 3 6 8
Vertigo 1 4 3 5
Back pain 2 2 2 5
Dysarthria 0 1 3 4
Anxiety 1 2 3 4
Blurred vision 1 1 3 4
Gait disturbance 1 1 4 4
Weight gain 1 4 4 4
Cough 3 1 1 4
Upper respiratory tract infection 3 3 3 4
Vomiting 3 2 3 4
Hypersomnia 0 1 2 3
Anger <1 0 1 3
Aggression 1 1 2 3
Balance disorder 1 0 5 3
Diplopia 1 1 1 3
Head injury 1 1 1 3
Hypoaesthesia 1 0 0 3
Pain in extremity 1 0 2 3
Constipation 2 2 2 3
Myalgia 2 1 1 3
Coordination abnormal 0 1 <1 2
Euphoric mood 0 0 <1 2
Confusional state <1 1 1 2
Hyponatremia <1 0 0 2
Limb injury <1 1 1 2
Mood altered <1 1 <1 2
Arthralgia 1 0 3 2
Asthenia 1 1 2 2
Contusion 1 0 2 2
Memory impairment 1 0 1 2
Musculoskeletal pain 1 1 1 2
Oropharyngeal pain 1 2 2 2
Paraesthesia 1 0 1 2
Peripheral edema 1 1 1 2
Skin laceration 1 0 2 2
Primary Generalized Tonic-Clonic Seizures
A total of 81 patients receiving FYCOMPA 8 mg once daily constituted the safety population in the placebo-controlled trial in patients with primary generalized tonic-clonic seizures (Study 4). Approximately 57% of patients were female, and the mean age was 27 years.
In the controlled primary generalized tonic-clonic seizure clinical trial (Study 4), the adverse reaction profile was similar to that noted for the controlled partial-onset seizure clinical trials (Studies 1, 2, and 3).
Table 3 gives the incidence of adverse reactions in patients receiving FYCOMPA 8 mg (≥4% and higher than in the placebo group) in Study 4. The most common adverse reactions in patients receiving FYCOMPA (≥10% and greater than placebo) were dizziness (32%), fatigue (15%), headache (12%), somnolence (11%), and irritability (11%).
The adverse reactions most commonly leading to discontinuation in patients receiving FYCOMPA 8 mg (≥2% and greater than placebo) were vomiting (2%) and dizziness (2%).
Table 3. Adverse Reactions in a Placebo-Controlled Trial in Patients with Primary Generalized Tonic-Clonic Seizures (Study 4) (Reactions ≥ 4% of Patients in FYCOMPA Group and More Frequent than Placebo) Placebo
n=82
% FYCOMPA 8 mg
n=81
%
Dizziness 6 32
Fatigue 6 15
Headache 10 12
Somnolence 4 11
Irritability 2 11
Vertigo 2 9
Vomiting 2 9
Weight gain 4 7
Contusion 4 6
Nausea 5 6
Abdominal pain 1 5
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