New drug approvals
Reports from the field-FDA OKs new drug for seizure control
The U.S. Food and Drug Administration (FDA) in Rockville, MD, recently approved a new use for the anti-epileptic drugs Topamax (topiramate) tablets and Topamax Sprinkle Capsules (topiramate capsules) manufactured by Ortho-McNeill Pharmaceuticals in Raritan, NJ, as add- on treatment for primary generalized tonic-clonic seizures in adults and children ages 2 to 16. With its previous indication as an add-on treatment of partial onset seizures in adults and pediatric patients, Topamax now can be used to treat the majority of seizures affecting the 2.3 million Americans diagnosed with epilepsy.
Topamax was approved by the FDA in 1996 as an add-on treatment for adults with partial onset seizures. In July 1999, it was approved as the first newer generation anti-epileptic drug to treat partial onset seiz ures as an add-on therapy in pediatric patients as young as 2.
The drug 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% of patients receiving Topamax as add-on therapy with baseline anti-epileptic drugs experienced at least a 50% reduction in primary generalized tonic-clonic seizures, compared with 20% of patients given placebo. A reduction of seizure frequency of at least 75% was experienced by 33% of Topamax-treated patients, compared with 13% of patients on placebo. In addition, 13% of Topamax-treated patients became seizure-free, compared with 5% of patients given placebo.
For more details, visit www.topamax.com or call (800) 682-6532.
FDA approves drug to regulate heartbeat
The U.S. Food and Drug Administration in Rockville, MD, recently approved the anti-arrhythmic agent Tikosyn (dofetilide) by New York City-based Pfizer.
Tikosyn is indicated for the maintenance and conversion of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter. Tikosyn is the first new oral anti-arrhythmic for atrial fibrillation to be approved in the United States in 10 years. Findings of a 8,500-patient study of the drug in this country and a 1,500-patient trial of the drug conducted by Danish researchers include:
• Tikosyn was effective in maintaining patients in normal sinus rhythm.
• Tikosyn did not increase mortality in severely ill heart patients.
• Risk of induced arrhythmia was reduced by in-hospital initiation of the drug and adherence to a dosing algorithm.
The last finding has led Pfizer to develop a comprehensive program to educate institutions and health care professionals on the required in-hospital initiation and on the dosing algorithm. The drug should be available in the first quarter of 2000 to prescribers and hospitals that have participated in the educational program.
For more details, visit www.pfizer.com.
Brain tumor drug gains fast-track designation
Neurocrine Biosciences in San Diego recently announced that the Food and Drug Admin is tration in Rockville, MD, has granted fast-track designation to the company's IL-4 Fusion Toxin compound (NBI-3001) for treatment of malignant brain tumors.
Preliminary results of a European study presented at the 13th International Conference on Brain Tumor Research held in San Diego in October show that MRI scans of patients treated with NBI-3001 displayed dramatic changes suggestive of cell death indicating that the drug has a robust anti-tumor effect. IL-4 Fusion Toxin is administered through a special catheter that permits delivery directly into the brain tumor. Early results from Phase II clinical trials indicate that, when administered in this fashion, IL-4 Fusion Toxin kills tumor cells but not healthy brain cells.
IL-4 Fusion Toxin is a protein in which a blood-cell-derived growth factor has been joined with a Pseudomonas exotoxin, a potent toxin that destroys cancer cells. IL-4 has a high affinity for IL-4 receptors, which are highly localized on malignant brain tumors but not on normal brain cells. The IL-4 binds tightly to the IL-4 receptors on the surface of the tumor cells and delivers the exotoxin directly into the cell, resulting in cell death.
For details, visit www.neurocrine.com.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content