Athena Neurosciences Inc. announced Tuesday that it has fileda new drug application (NDA) with the FDA for approval tomarket Zanaflex for treating spasticity of spinal cord originassociated with multiple sclerosis and spinal cord injury.
Zanaflex, or tizanidine hydrochloride, is an orally active agentthat reduces abnormal muscle tone and spasms withoutproducing muscle weakness. It is believed to achieve this bystimulating the alpha2-adrenergic receptor sites in the centralnervous system at spinal and supra-spinal levels. Athena ofSouth San Francisco, Calif., licensed Zanaflex from SandozPharma Ltd., which markets the drug in more than 25countries worldwide. (In Switzerland, it's known as Sirdalud; inJapan, it's called Ternelin.)
The license agreement, penned in May 1991, specified an up-front payment and royalties to Sandoz, and gave Athena(NASDAQ:ATHN) the exclusive rights to market the product inthe U.S. and Canada.
Athena conducted its own Phase III clinical testing oftizanidine in the U.S. It initiated those trials in late 1991 andcompleted the last one in August 1993, according tospokeswoman Rivka Sherman-Gold.
This is Athena's first NDA. "Zanaflex is the first drug in ourproduct development pipeline to reach this stage and, webelieve, is also the first new compound developed for thespasticity associated with multiple sclerosis and spinal cordinjury to be submitted for FDA review in many years," saidJohn Groom, president and chief executive officer of Athena.
-- Jennifer Van Brunt Senior Editor
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