Home       Treatment        Side Effects       Novartis       FDA Aproval

 

FDA Approval for Trileptal – Trileptal

The Food and Drug Administration-FDA of the United States has officially released the approval of the anti-epileptic branded medication Trileptal made from Oxcarbazepine by the world renowned pharmaceutical corporation Novartis, during January 2000. The drug has been approved for use in treatment as Mono-therapy and Adjunctive therapy in adults, adjunctive therapy for children of age between 4 and 16 years suffering from partial epileptic seizures. Trileptal-Oxcarbazepine is the anticonvulsant or anti-epileptic drug – AED which received the FDA approval for its use as above.

Recent clinical trials incorporate 6 multi-center randomized double blind controlled trials that were carried out for ascertaining the efficacy of Trileptal-Oxcarbazepine. Four of these studies investigated the medication as the mono-therapy, while two of the studies tested this drug as the adjunctive therapy. People that participated in the trials ranged between 8 and 66 years of age. The studies in which the drug was compared with the4 placebo, patients administered this drug lasted remarkably longer without having certain seizure episodes than the patients not taking this drug. Moreover, the higher dose of Trileptal showed the significantly longer period before the patients showed typical seizure symptoms.

In addition, two trials wherein the drug examined as an adjunct therapy of which in one case the patients were aged between 15 and 66 years and in the other the patients were between age of 3 and 17 years. Each of the patients in these trials was on 1-3 concomitant Anti-Epileptic Drugs. The dose was increased over a period of two weeks until the patient reached the assigned dosage or experienced the intolerance to the dosage in both the studies.
 

Home       Treatment        Side Effects       Novartis       FDA Aproval