Elan subsidiary Athena Neurosciences has been granted approval by the US Food and Drug Administration for its alpha-2 adrenoreceptor agonist Zanaflex (tizanidine hydrochloride). It is the first new oral treatment for spasticity to reach the US market in more than 20 years.
The approval is a major development for Elan, which is moving away from its traditional focus of drug formulation and delivery towards a marketing and drug discovery business. Elan and Athena completed their merger on July 1, and since then Elan has also exercised its option to acquire Advanced Therapeutic Systems (Marketletter September 16). Importantly, Zanaflex represents the first New Chemical Entity which Elan will self-market in the USA, although subsidiary Athena has marketing experience with some specialist drugs such as Permax (pergolide).
The product is indicated for "the management of increased muscle tone associated with spasticity," which can occur as a result a number of central nervous system disorders, notably multiple sclerosis and spinal cord injury.
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