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NA | ZONISAMIDE [STAT RX USA LLC] | BioPortfolio

11:54 EST 27th January 2019 | BioPortfolio

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Zonisamide capsule is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is CHNOS with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is:

Zonisamide capsules are supplied for oral administration as capsules containing 25 mg, 50 mg and 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal silicon dioxide, sodium starch glycolate, talc, gelatin, titanium dioxide. For 100 mg D&C red # 28, D&C yellow # 10, and FD&C # yellow 6 and for 50 mg contains FD&C red # 40, FD&C yellow # 5, and FD&C Blue # 1.

Table 1. Median % Reduction in All Partial Seizures and % Responders in Primary Efficacy Analyses: Intent-To-Treat Analysis
Study Median % reduction in partial                                            seizures               %Responders
Zonisamide Capsules Placebo Zonisamide Capsules Placebo
Study 1: n=98 n=72 n=98 n=72
Weeks 8-12: 40.5%* 9.0% 41.8%* 22.2%
Study 2: n=69 n=72 n=69 n=72
Weeks 5-12: 29.6%* -3.2% 29.0% 15.0%
Study 3: n=67 n=66 n=67 n=66
Weeks 5-12: 27.2%* -1.1% 28.0%* 12.0%
Table 2. Median % Reduction in All Partial Seizures and % Responders for Dose Analyses in Study 1: Intent-To-Treat Analysis
Dose Group Median % reduction in partial                                            seizures               %Responders
Zonisamide Capsules Placebo Zonisamide Capsules Placebo
100-400 mg/day: n=112 n=83 n=112 n=83
Weeks 1-12: 32.3%* 5.6% 32.1%* 9.6%
100 mg/day: n=56 n=80 n=56 n=80
Weeks 1-5: 24.7%* 8.3% 25.0%* 11.3%
200 mg/day: n=55 n=82 n=55 n=82
Weeks 2-6: 20.4%* 4.0% 25.5%* 9.8%
Table 3: Risk by indication for antiepileptic drugs in the pooled analysis
Indication
Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence  of Events in Drug Patients/Incidence in Placebo Patients
Risk Difference: Drug Patients with Events Per 1000 Patients
Epilepsy                           1.0
                          3.4 
                                                    3.5                                      2.4
Psychiatric
                          5.7
                          8.5
                                                    1.5                                      2.9
Other                           1.0
                          1.8                                                     1.9
                                     0.9
Total
                          2.4
                          4.3
                                                    1.8                                      1.9
TABLE 4: Incidence (%) of Treatment-Emergent Adverse Events in Placebo-Controlled, Add-On Trials (Events that occurred in at least 2% of zonisamide capsules-treated patients and occurred more frequently in zonisamide capsules-treated than placebo-treated patients)
BODY SYSTEM/PREFERRED TERM Zonisamide Capsules
(n=269)
%
Placebo
(n=230)
%
BODY AS A WHOLE
  Headache 10 8
  Abdominal Pain 6 3
  Flu Syndrome 4 3
DIGESTIVE
  Anorexia 13 6
  Nausea 9 6
  Diarrhea 5 2
  Dyspepsia 3 1
  Constipation 2 1
  Dry Mouth 2 1
HEMATOLOGIS AND LYMPHATIC
  Ecchymosis 2 1
METABOLIC AND NUTRITIONAL
  Weight Loss 3 2
NERVOUS SYSTEM
  Dizziness 13 7
  Ataxia 6 1
  Nystagmus 4 2
  Paresthesia 4 1
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-ALERTED COGNITIVE FUNCTION
  Confusion 6 3
  Difficulty Concentrating 6 2
  Difficulty with Memory 6 2
  Mental Slowing 4 2
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (NON-PSYCHOSIS-RELATED)
  Agitation/Irritability 9 4
  Depression 6 3
  Insomnia 6 3
  Anxiety 3 2
  Nervousness 2 1
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (PSYCHOSIS-RELATED)
  Schizophrenic/Schizophreniform Behavior 2 0
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-CNS DEPRESSION
  Somnolence 17 7
  Fatigue 8 6
  Tiredness 7 5
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-SPEECH AND LANGUAGE ABNORMALITIES
  Speech Abnormalities 5 2
  Difficulties in Verbal Expression 2 <1
RESPIRATORY
  Rhinitis 2 1
SKIN AND APPENDAGES
  Rash 3 2
SPECIAL SENSES
  Diplopia 6 3
  Taste Perversion 2 0
Strength
Description
Pack
NDC No.
25 mg
White opaque body, imprinted with W945 and White opaque cap, containing white powder.
Bottle of 100
64679-945-01
50 mg
White opaque body, imprinted with W946 and Grey opaque cap, containing white powder.
Bottle of 100
64679-946-01
100 mg
White opaque body, imprinted with W990 and Orange opaque cap, containing white powder.
Bottle of 100
64679-990-01

Manufacturer

STAT RX USA LLC

Active Ingredients

Source

Drugs and Medications [44 Associated Drugs and Medications listed on BioPortfolio]

Zonisamide [directrx]

ZONISAMIDE

Zonisamide [wockhardt limited]

Product Information Zonisamide Capsules Rx Only

Zonisamide [zydus pharmaceuticals (usa) inc.]

Zonisamide Capsules

Zonisamide [cadila healthcare limited]

Zonisamide Capsules

Zonisamide [american health packaging]

Zonisamide Capsules USP 8423065/0618 Rx only

Clinical Trials [37 Associated Clinical Trials listed on BioPortfolio]

Fed Bioavailability Study of Zonisamide Capsules

The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zo...

Safety and Efficacy of Different Combinations of Zonisamide-CR Plus Bupropion-SR to Treat Uncomplicated Obesity

The purpose of this study is to determine which of seven combinations of Zonisamide CR and Bupropion SR gives the best weight loss and is safe and well tolerated for the treatment of obesi...

Fasting Bioavailability Study of Zonisamide Capsules

The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® ...

Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myocl...

Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

PubMed Articles [6 Associated PubMed Articles listed on BioPortfolio]

Clinical experience of using zonisamide in structural focal epilepsy in children with cerebral palsy.

To evaluate the efficacy and safety of zonisamide as an add-on therapy in structural focal epilepsy in children with cerebral palsy (CP).

Treatment of intractable resting tremor of spinocerebellar ataxia 42 with zonisamide.

Strategies of using the new antiepileptic drugs for epilepsy in adults.

The new antiepileptic drugs have not changed the basic pharmacological treatment principles of epilepsy, but they have given greater choice in focal and in generalized epilepsies as well. The new drug...

Major Congenital Malformations Associated With Exposure to Antiepileptic Drugs During Pregnancy.

Antiepileptic drugs (AEDs) are prescribed for approved and off-label indications that include epilepsy, bipolar disorder, and other neurologic and psychiatric disorders. The risk of major congenital m...

Effect of newer anti-epileptic drugs (AEDs) on the cognitive status in pentylenetetrazol induced seizures in a zebrafish model.

Epilepsy is marked by seizures that are a manifestation of excessive brain activity and is symptomatically treatable by anti-epileptic drugs (AEDs). Unfortunately, the older AEDs have many side effect...

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