To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Topamax For Combo Treatment Of Seizures URL: http://www.pslgroup.com/dg/1127DA.htm Doctor's Guide October 5, 1999
RARITAN, N.J. -- October 5, 1999 -- The U.S. Food and Drug Administration (FDA) approved a new use for the anti-epileptic drug Topamax® (topiramate) Tablets and Topamax (topiramate capsules) Sprinkle Capsules as add-on treatment for primary generalized tonic-clonic seizures in adults and pediatric patients ages two to 16 years.
With its previous indication as add-on treatment of partial onset seizures in adults and pediatric patients (ages two to 16 years), Topamax can now be used to treat the majority of seizures affecting the 2.3 million Americans diagnosed with epilepsy.
Seizures, the hallmark of epilepsy, are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as either "generalized," when the abnormal discharge affects both sides of the brain simultaneously, or "partial," when the discharge affects one part of the brain initially.
About 40 percent of people with epilepsy have generalized seizures, and more than half of them experience primary generalized tonic-clonic seizures, sometimes referred to as "grand mal seizures." An individual suffering a primary generalized tonic-clonic seizure will lose consciousness, fall, stiffen, and experience forceful muscle jerking before slowly regaining consciousness.
Roughly 57 percent of people with epilepsy experience partial onset seizures, including about half of the 750,000 children in the U.S. with epilepsy. Partial onset seizures can cause sensory distortion, uncontrolled movements and, in some cases, an altered, trance-like consciousness.
"Topiramate now offers hope to many patients diagnosed with either type of seizure that has not been controlled with other medications," said Victor Biton, M.D., director of the Arkansas Epilepsy Program and lead investigator in the Topamax clinical trials. "With this new indication, topiramate is an effective medication to treat most seizures, in patients ranging from young children to adults."
Topamax was first approved by the FDA in 1996 as add-on treatment for adults with partial onset seizures. In July 1999, Topamax was approved as the first "newer generation" anti-epileptic drug to treat partial onset seizures as add-on therapy in pediatric patients as young as two. Topiramate is approved for marketing in more than 60 countries and to date, has been used to treat seizures in more than 300,000 patients worldwide.
Approximately 25 percent of Americans diagnosed with epilepsy have seizures that resist treatment with traditional anti-epileptic drugs (AEDs), according to a recent report by the Epilepsy Foundation, a national organization serving people with epilepsy. Physicians may prescribe an add-on medication, such as Topamax, when their patients fail to respond to a single anti-epileptic drug. The newer generation anti-epileptic drugs, developed since 1993, generally are associated with fewer side effects than earlier medications.
Topamax was tested in patients with primary generalized tonic-clonic seizures in a double-blind, randomized, placebo-controlled study at 20 sites with a total of 80 patients. In that trial, 56 percent of patients receiving Topamax as add-on therapy with baseline AEDs experienced at least a 50 percent reduction in primary generalized tonic-clonic seizures vs. 20 percent of patients given placebo. A reduction in seizure frequency of at least 75 percent was experienced by 33 percent of Topamax-treated patients vs. 13 percent of patients given placebo, and 13 percent of Topamax-treated patients vs. 5 percent of patients given placebo became seizure-free during the trial.
In clinical trials, in combination with traditional AEDs, the most common side effects associated with Topamax in pediatric patients included excessive drowsiness, loss of appetite, fatigue, nervousness, difficulty with concentration/attention, weight decrease, aggressive reaction and difficulty with memory. The safety and effectiveness in patients younger than two have not been established. In adults, the most common types of side effects were somnolence, dizziness, coordination problems, speech disorders, psychomotor slowing, abnormal vision, difficulty with memory, sensory distortion and double vision.
Topamax is available as a tablet and in a capsule formulation that can be opened and sprinkled onto food for easy swallowing. The capsule also can be swallowed whole, offering patients greater flexibility.
Topamax was discovered and developed by the R.W. Johnson Pharmaceutical Research Institute, and is marketed in the United States by Ortho-McNeil Pharmaceutical, both Johnson & Johnson companies.
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