Athena regulatory update
In October, ATHN presented data on a Phase III trial in spasticity in multiple sclerosis at the American Physiological Society meeting on Physiology and Pharmacology of Motor Control in San Diego. The 15-site, double-blind study compared Zanaflex to placebo. Primary endpoints were change in muscle tone assessed by the Ashworth scale and daily spasms and clonus (involuntary alternate muscle contraction and relaxation) recorded in patient diaries.
Most of the patients received dosages in the 24-36 mg/day range. There were 220 patients enrolled and treated and 155 evaluable patients. There were no differences in muscle tone between the treatment and placebo groups. However, diary counts of spasm and clonus were significantly reduced in the Zanaflex group compared to placebo. Global evaluations by patients and investigators were statistically significant in favor of the treatment group. ...