Jan. 21, 2009Products
Parkinson's disease drug "TRERIEF" obtained manufacturing and marketing approval
Dainippon Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada) announces that the Company has obtained a manufacturing and marketing approval for “TRERIEF® tablet 25mg” (generic name: zonisamide) as of January 21, 2009 from Ministry of Health, Labor and Welfare.
Zonisamide is a chemical compound that was created by the Company. This product was put on the market as an antiepileptic agent under the product name of EXCEGRAN® in 1989. Since then it has been extensively used under approvals by 36 countries in the world. When this product was administered to a Japanese patient with Parkinson's disease for the specific purpose of treating convulsion attacks which occurred to this particular patient, the convulsion attacks disappeared and simultaneously the symptoms of Parkinson's disease were alleviated. Based on this finding, since 2001 the Company has pursued a program to develop this drug as an agent to cure Parkinson's disease.
Parkinson's disease has a higher morbidity next to Alzheimer's disease among neurodegenerative diseases. Its major symptoms are such movement disorders as tremor at rest, muscle rigidity, akinesia, and impairment of postural reflexes.
Parkinson's disease occurs from lack of dopamine at nerve terminals, and its standard therapies are medication to correct the deficiency in function of dopamine.
In clinical trials of TRERIEF®, such beneficial effects as improvement in movement ability and betterment in activities of daily living have been found in those patients with advanced Parkinson's disease who are not sufficiently cured by any of the above-mentioned standard therapies.
The Company intends to launch TRERIEF® only after the national health insurance price listing is effected and hopes this drug contributes to therapies of Parkinson's disease.
|[Brand Name]||TRERIEF®||[Generic Name]||zonisamide||[Content / Description]||Pale yellow film-coated oval tablets, containing 25mg of zonisamide per tablet||[Indication]||Parkinson's disease (to be administered in case sufficient effects are not obtained even though any of other Parkinson's disease drugs is administered besides a levodopa-containing agent)||[Dosage and Administration]||TRERIEF®(zonisamide) should be administered in association with levodopa agent The dose of TRERIEF® (zonisamide) for adults is usually 25mg once daily.||[Manufacturer and Distributor]||Dainippon Sumitomo Pharma Co., Ltd.|