If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Albenza Cleared by FDA for Treatment of Two Rare Parasitic Infections PHILADELPHIA, June 12, 1996 -- SmithKline Beecham (NYSE: SBH) today announced that its Albenza(TM) (albendazole) Tablets have been cleared for marketing by the US Food and Drug Administration (FDA) for the treatment of two parasitic infections caused by worms: -- hydatid cyst disease of the liver, lung and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus, and -- neurocysticercosis caused by larval forms of the pork tapeworm, Taenia solium. Albenza is the first medication cleared by the FDA in the US for the treatment of these rare infections. E. granulosus is considered endemic in the Western US sheep-raising areas of Utah, Arizona and Nevada, but the vast majority of cases occur in new immigrants who have been exposed to the infection years previously in their countries of origin, or in travelers from the US to endemic areas. Most cysts are found in the liver where, after remaining asymptomatic for decades, they finally produce abdominal pain or a mass. The incidence of hydatid disease in the US is estimated to be between 100 and 200 new cases diagnosed annually. T. solium cysticercosis is rare in the US except in immigrants from endemic areas. It is most common in Latin America, Asia, Russia and Eastern Europe and is caused by inadequately cooked or raw infected pork. Infection with the adult worm is usually asymptomatic. Severe larval infection, a result of ingestion of contaminated material, may cause muscle pains, weakness or fever. It can also cause epileptic seizures. The incidence of neurocysticercosis is estimated to be less than 1,000 new cases diagnosed annually. Patients treated with Albenza have shown improvement in more than 80 percent of the neurocysticercosis patients and cure or improvement in up to 70 percent of the hydatid patients. Side effects were usually mild and resolved without treatment. The most frequently reported side effects by hydatid disease patients included abnormal liver function, abdominal pain, nausea and vomiting; those reported by neurocysticercosis patients included headache, nausea and vomiting. For hydatid disease, the recommended dose for Albenza is 400 mg twice daily with meals for three cycles (each cycle consists of 28 days of dosing followed by a 14-day albendazole-free interval). For neurocysticercosis, the recommended dose is 400 mg twice daily for 8-30 days. Worldwide, the prevalence of hydatid disease is estimated to be about 1 million people mostly found in herding and animal-raising countries and regions of North West China, parts of Northern and Southern Africa, East Africa, Iraq, the Mediterranean basin, Uruguay, Argentina and Chile. It also occurs occasionally in other countries including the US, Great Britain, South and East Europe, Australia and New Zealand. The prevalence of neurocysticercosis is estimated to be about 1.5 million people worldwide. In both diseases, infection with the larva is accidental and transmission from human-to-human does not normally occur. Albendazole was first marketed outside the US in 1982 for human use where it is currently marketed under the tradenames of Zentel(R) and Eskazole(R). SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides healthcare services including clinical laboratory testing, disease management and pharmaceutical benefit management.
|
