What is Inovelon?
Inovelon is a drug containing the active substance rufinamide. It is available as pink oval tablets containing 100 mg, 200 mg or 400 mg rufinamide.
What is Inovelon used for?
Inovelon is indicated in patients aged 4 years and over in the treatment of Lennox-Gastaut syndrome, a rare form of epilepsy that normally affects children but can continue into adulthood. Lennox-Gastaut syndrome is one of the most serious forms of epilepsy in children. Symptoms include various forms of crisis, excessive electrical activity in the brain, learning difficulties and behavioral disorders. Inovelon is indicated as an adjunctive therapy to other antiepileptic drugs.
Since the number of patients with Lennox-Gastaut syndrome is low, the disease is considered rare and Inovelon was designated an "orphan medicine" (a medicine used in rare diseases) on 20 October 2004.
The medicine can only be obtained with a prescription.
How is Inovelon used?
Treatment with Inovelon should be started by a pediatrician or neurologist (a doctor who specializes in treating nervous system disorders) with experience in treating epilepsy.
The dose of Inovelon depends on the age and weight of the patient as well as on the concomitant intake of valproate (another anti-epileptic drug). Treatment usually starts with a daily dose of 200 or 400 mg, a dose that is then modified based on the patient's response.
Inovelon should be taken with water and food twice a day, in the morning and in the evening. If the patient has difficulty swallowing, the tablets can be crushed and mixed in a glass of water. Inovelon should be used with caution in subjects with liver disorders. For more information, see the package leaflet.
How does Inovelon work?
The active substance in Inovelon, rufinamide, is an anti-epileptic drug. It works by adhering to special channels on the surface of nerve cells in the brain (so-called sodium channels) that control the electrical activity of cells. By adhering to these channels, rufinamide prevents them from passing from a state of inactivity to a state of activity. In this way the activity of nerve cells
is reduced and it is therefore possible to prevent the spread of excessive electrical activity in the brain, reducing the likelihood of epileptic seizures.
What studies have been carried out on Inovelon?
The effects of Inovelon were first tested in experimental models before being studied in humans.
The main study on Inovelon involved 139 patients aged between 4 and 30, of whom three quarters were less than 17 years old. All patients had uncontrolled Lennox-Gastaut syndrome, despite the administration of continuous treatment for at least 4 weeks with other antiepileptic drugs (from 1 to 3). The study compared the effects of Inovelon with placebo (a substance without effects on the body) as an adjunctive therapy combined with other drugs taken by patients. The main measures of effectiveness were the change in the number of seizures in the 4 weeks following the administration of Inovelon or placebo compared to the 4 weeks before the addition of this therapy, as well as the variation in the severity of the seizures based on the evaluation carried out by the parent or by the tutor on the basis of a 7-point scale.
What benefit has Inovelon shown during the studies?
Inovelon reported a reduction in the number and severity of the crises. Patients who took Inovelon reported a 35.8% reduction in the total number of seizures compared to an average of 290 seizures in the 4 weeks preceding the start of treatment with Inovelon. On the other hand, patients treated with placebo registered a 1.6% reduction.
Patients who took Inovelon also reported a 42.5% decrease in the number of "tonic-atonic" seizures (a type of frequent seizure in patients with Lennox-Gastaut syndrome, characterized by easy falls to the ground) compared to 1.9% increase observed in patients treated with placebo.
About half of the patients taking Inovelon experienced an improvement in seizure severity compared to one-third of placebo-treated subjects.
What are the risks associated with Inovelon?
The most common side effects with Inovelon (seen in more than 1 patient in 10) are drowsiness, headache, dizziness, nausea, vomiting and fatigue. For the full list of all side effects reported with Inovelon, see the Package Leaflet.
Inovelon must not be used in people who are hypersensitive (allergic) to rufinamide, derived from triazole (such as some medicines used to treat fungal infections) or to any of the excipients.
Why has Inovelon been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Inovelon's benefits are greater than its risks for the treatment, as an adjunctive therapy, of crises associated with Lennox-Gastaut syndrome in patients from 4 years of age, and he therefore recommended that he be given a marketing authorization.
What measures are being taken to ensure the safe use of Inovelon?
The company that makes Inovelon will carefully monitor the safety of the medicine. This monitoring also includes the observation of cases of "status epilepticus", a dangerous condition in which the brain is in a state of continuous crisis. This is due to the fact that cases of this type have been observed in subjects who have taken Inovelon during its development.
More information on Inovelon:
On 16 January 2007, the European Commission issued a marketing authorization valid for Inovelon, valid throughout the European Union, to Eisai Limited.
The summary of the opinion of the Committee for Orphan Medicinal Products on Inovelon is available here.
For the full version of the evaluation (EPAR) of Inovelon, click here.
Last update of this summary: 01-2007.
