CONFIDENCE IN A FULL DOSE.1

Efficacy and Safety

SYMPAZAN (clobazam) is proven bioequivalent to clobazam1,2

In a single-dose, open-label, randomized, 4-period, 4-sequence, 4-treatment, crossover pharmacokinetic study with 51 healthy subjects, SYMPAZAN with PharmFilm® technology demonstrated bioequivalence to clobazam.1

Mean Plasma Concentration Profiles: SYMPAZAN vs Clobazam1

The mean plasma concentration profiles of SYMPAZAN and clobazam tablets are shown to be similar in this PK chart.

In clinical studies, clobazam, the active ingredient in SYMPAZAN, has been shown to reduce weekly drop seizures from 41% to 68%2*

Reduction in Weekly Rates of Drop Seizures (%)2

In clinical studies, clobazam, the active ingredient in SYMPAZAN, has been shown to reduce weekly drop seizures from 41% to 68%.

The primary efficacy measure was the percent reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic), also known as drop attacks, from the 4-week baseline period to 4-week maintenance period.2

*Study 1 (N=238) was a randomized, double-blind, placebo-controlled study consisting of a 4-week baseline period followed by a 3-week titration period and 12-week maintenance period. Patients age 2-54 years with a current or prior diagnosis of LGS were stratified into 2 weight groups (12.5 kg to ≤30 kg or >30 kg) and then randomized to placebo or 1 of 3 target maintenance doses of clobazam. Subjects experiencing a 41% reduction in weekly drop-seizure frequency took doses of 5 mg daily per ≤30 kg of body weight or 10 mg daily per >30 kg of body weight. Subjects experiencing a 49% reduction in weekly drop-seizure frequency took doses of 10 mg daily per ≤30 kg of body weight or 20 mg daily per >30 kg of body weight. Subjects experiencing a 68% reduction in weekly drop-seizure frequency took doses of 20 mg daily per ≤30 kg of body weight or 40 mg daily per >30 kg of body weight.2

Adverse reactions

The Most Common Adverse Reactions (≥10%)2:

  • Constipation
  • Pyrexia
  • Irritability
  • Upper respiratory tract infection
  • Somnolence or sedation
  • Lethargy
  • Drooling
  • Ataxia
  • Aggression
  • Constipation
  • Pyrexia
  • Irritability
  • Upper respiratory tract infection
  • Somnolence or sedation
  • Lethargy
  • Drooling
  • Ataxia
  • Aggression

Adverse Reactions Reported for ≥5% of Patients and More Frequently Than Placebo in Any Treatment Group2

Clobazam Dose Level
Placebo N=59
%		 Lowa N=58
%		 Mediumb N=62
%		 Highc N=59
%		 All Clobazam N=179
%
Gastrointestinal Disorders
Vomiting 5 9 5 7 7
Constipation 0 2 2 10 5
Dysphagia 0 0 0 5 2
General Disorders and Administration Site Conditions
Pyrexia 3 17 10 12 13
Irritability 5 3 11 5 7
Fatigue 2 5 5 3 5
Infections and Infestations
Upper respiratory tract infection 10 10 13 14 12
Pneumonia 2 3 3 7 4
Urinary tract infection 0 2 5 5 4
Bronchitis 0 2 0 5 2
Metabolism and Nutrition Disorders
Decreased appetite 3 3 0 7 3
Increased appetite 0 2 3 5 3
Nervous System Disorders
Somnolence or sedation 15 17 27 32 26
Somnolence 12 16 24 25 22
Sedation 3 2 3 9 5
Lethargy 5 10 5 15 10
Drooling 3 0 13 14 9
Ataxia 3 3 2 10 5
Psychomotor hyperactivity 3 3 3 5 4
Dysarthria 0 2 2 5 3
Psychiatric Disorders
Aggression 5 3 8 14 8
Insomnia 2 2 5 7 5
Respiratory Disorders
Cough 0 3 5 7 5
aMaximum daily dose of 5 mg for ≤30 kg body weight; 10 mg for >30 kg body weight.
bMaximum daily dose of 10 mg for ≤30 kg body weight; 20 mg for >30 kg body weight.
cMaximum daily dose of 20 mg for ≤30 kg body weight; 40 mg for >30 kg body weight.
Gastrointestinal Disorders
Vomiting %
Placebo N=59
%		 5
Lowa N=58
%		 9
Mediumb N=62
%		 5
Highc N=59
%		 7
All Clobazam N=179
%		 7
Constipation %
Placebo N=59
%		 0
Lowa N=58
%		 2
Mediumb N=62
%		 2
Highc N=59
%		 10
All Clobazam N=179
%		 5
Dysphagia %
Placebo N=59
%		 0
Lowa N=58
%		 0
Mediumb N=62
%		 0
Highc N=59
%		 5
All Clobazam N=179
%		 2
General Disorders and Administration Site Conditions
Pyrexia %
Placebo N=59
%		 3
Lowa N=58
%		 17
Mediumb N=62
%		 10
Highc N=59
%		 12
All Clobazam N=179
%		 13
Irritability %
Placebo N=59
%		 5
Lowa N=58
%		 3
Mediumb N=62
%		 11
Highc N=59
%		 5
All Clobazam N=179
%		 7
Fatigue %
Placebo N=59
%		 2
Lowa N=58
%		 5
Mediumb N=62
%		 5
Highc N=59
%		 3
All Clobazam N=179
%		 5
Infections and Infestations
Upper respiratory tract infection %
Placebo N=59
%		 10
Lowa N=58
%		 10
Mediumb N=62
%		 13
Highc N=59
%		 14
All Clobazam N=179
%		 12
Pneumonia %
Placebo N=59
%		 2
Lowa N=58
%		 3
Mediumb N=62
%		 3
Highc N=59
%		 7
All Clobazam N=179
%		 4
Urinary tract infection %
Placebo N=59
%		 0
Lowa N=58
%		 2
Mediumb N=62
%		 5
Highc N=59
%		 5
All Clobazam N=179
%		 4
Bronchitis %
Placebo N=59
%		 0
Lowa N=58
%		 2
Mediumb N=62
%		 0
Highc N=59
%		 5
All Clobazam N=179
%		 2
Metabolism and Nutrition Disorders
Decreased appetite %
Placebo N=59
%		 3
Lowa N=58
%		 3
Mediumb N=62
%		 0
Highc N=59
%		 7
All Clobazam N=179
%		 3
Increased appetite %
Placebo N=59
%		 0
Lowa N=58
%		 2
Mediumb N=62
%		 3
Highc N=59
%		 5
All Clobazam N=179
%		 3
Nervous System Disorders
Somnolence or sedation %
Placebo N=59
%		 15
Lowa N=58
%		 17
Mediumb N=62
%		 27
Highc N=59
%		 32
All Clobazam N=179
%		 26
Somnolence %
Placebo N=59
%		 12
Lowa N=58
%		 16
Mediumb N=62
%		 24
Highc N=59
%		 25
All Clobazam N=179
%		 22
Sedation %
Placebo N=59
%		 3
Lowa N=58
%		 2
Mediumb N=62
%		 3
Highc N=59
%		 9
All Clobazam N=179
%		 5
Lethargy %
Placebo N=59
%		 5
Lowa N=58
%		 10
Mediumb N=62
%		 5
Highc N=59
%		 15
All Clobazam N=179
%		 10
Drooling %
Placebo N=59
%		 3
Lowa N=58
%		 0
Mediumb N=62
%		 13
Highc N=59
%		 14
All Clobazam N=179
%		 9
Ataxia %
Placebo N=59
%		 3
Lowa N=58
%		 3
Mediumb N=62
%		 2
Highc N=59
%		 10
All Clobazam N=179
%		 5
Psychomotor hyperactivity %
Placebo N=59
%		 3
Lowa N=58
%		 3
Mediumb N=62
%		 3
Highc N=59
%		 5
All Clobazam N=179
%		 4
Dysarthria %
Placebo N=59
%		 0
Lowa N=58
%		 2
Mediumb N=62
%		 2
Highc N=59
%		 5
All Clobazam N=179
%		 3
Psychiatric Disorders
Aggression %
Placebo N=59
%		 5
Lowa N=58
%		 3
Mediumb N=62
%		 8
Highc N=59
%		 14
All Clobazam N=179
%		 8
Insomnia %
Placebo N=59
%		 2
Lowa N=58
%		 2
Mediumb N=62
%		 5
Highc N=59
%		 7
All Clobazam N=179
%		 5
Respiratory Disorders
Cough %
Placebo N=59
%		 0
Lowa N=58
%		 3
Mediumb N=62
%		 5
Highc N=59
%		 7
All Clobazam N=179
%		 5
aMaximum daily dose of 5 mg for ≤30 kg body weight; 10 mg for >30 kg body weight.
bMaximum daily dose of 10 mg for ≤30 kg body weight; 20 mg for >30 kg body weight.
cMaximum daily dose of 20 mg for ≤30 kg body weight; 40 mg for >30 kg body weight.