Tonic Clonic Seizure

CHMP summary of positive opinion for Matever

LONDON, Jul 22 2011, -- On 21 July 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Matever 250 mg, 500 mg, 750 mg and 1000 mg film-coated tablets and 100 mg/ml concentrate for solution for infusion intended for the treatment of epilepsy. The applicant for this medicinal product is Pharmathen S.A. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The active substance of Matever is levetiracetam, an antiepileptic agent (ATC code: N03AX14). Levetiracetam is a pyrrolidone derivative chemically unrelated to existing antiepileptic active substances. The mechanism of action of levetiracetam still remains to be fully elucidated but appears to be different from the mechanisms of current antiepileptic medicinal products. In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.

Matever is a generic of Keppra, which has been authorised in the EU since 29 September 2000. Studies have demonstrated the satisfactory quality of Matever and its bioequivalence with Keppra. For more information on generic medicines, see the question-and-answer document.

The approved indication is as follows:

“Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.

Levetiracetam is indicated as adjunctive therapy:

* in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy. * in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.”

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR), and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CHMP, on the basis of data submitted, considers there to be a favourable benefit to risk balance for Matever and therefore recommends the granting of the marketing authorisation.

Medicine science » Generalized Tonic-Clonic Seizures

A seizure is an abnormal paroxysmal discharge of cerebral neurons due to cortical hyperexcitability. The International Classification of Seizures divides seizures into 2 categories: partial seizures (ie, focal or localization-related seizures) and generalized seizures.

Partial seizures result from a seizure discharge within a particular brain region or focus, and they manifest focal symptoms and may progress to secondarily generalized seizure. Primary generalized seizures probably begin in the thalamus and other subcortical structures, but on scalp electroencephalographic (EEG) recordings, they may appear to start simultaneously in both cerebral hemispheres; therefore, they manifest symptoms bilaterally in the body and are always associated with loss of consciousness.

Partial seizures can generalize secondarily and result in tonic-clonic activity. Some partial seizures have very rapid generalization, and the partial phase of the seizure may not be readily apparent clinically or even on scalp EEG recordings. However, secondarily generalized partial seizures are not included in the category of generalized seizures, which includes only primary generalized seizures.

Generalized seizures can be classified as atonic, tonic, clonic, tonic-clonic, myoclonic, or absence on the basis of clinical symptoms and EEG abnormalities. Tonic seizure is the rigid contracture of muscles, including respiratory muscles, which is usually brief. The clonic component is the rhythmic shaking that occurs and is longer. Together, a generalized tonic-clonic seizure (GTCS) is also called a grand mal seizure and is one of the most dramatic of all medical conditions.

The following epilepsy syndromes have generalized seizures:

Patients with generalized tonic-clonic seizures and idiopathic generalized epilepsy typically have no evidence of any localized, regional, or diffuse brain abnormality on history, physical, or neurologic examination; clinical laboratory testing; or imaging studies. The awake EEG of patients with generalized tonic-clonic seizure may be normal; however, certain specific interictal EEG patterns can be distinctive of generalized epilepsy syndromes (see Workup).

A number of medications are used for the treatment of generalized tonic-clonic seizures. The choice of drug should be tailored to the individual patient and to the epilepsy syndrome, not only to the seizure type (see Treatment and Management, as well as Medication).

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