7:47AM Acorda Therapeutics presents positive dalfampridine-ER data in post-stroke deficits at American Neurological Association 2013 Annual Meeting; treatment with dalfampridine-ER was well-tolerated and improved walking (ACOR) 35.34 : Co announced data from a Phase 2 proof-of-concept study of dalfampridine extended release tablets, 10 mg (dalfampridine-ER) in people with post-stroke deficits. In the study, treatment with dalfampridine-ER was well-tolerated and improved walking, as measured by the Timed 25-Foot Walk test (T25FW). The data were presented at the American Neurological Association 2013 Annual Meeting, being held in New Orleans. Top-line data from this study were disclosed by the co in April 2013.
The safety findings in this study were consistent with previous clinical trials and post-marketing experience of dalfampridine-ER in multiple sclerosis. The overall rate of treatment-emergent adverse events was 54.5% and 37.0% for dalfampridine-ER and placebo, respectively. The most common adverse events reported in the study were dizziness (10.4% dalfampridine-ER, 2.5% placebo), nausea (3.9% dalfampridine-ER, 6.2% placebo), fatigue (5.2% dalfampridine-ER, 3.7% placebo), insomnia (5.2% dalfampridine-ER, 2.5% placebo) and arthralgia (2.6% dalfampridine-ER, 3.7% placebo). Three participants experienced a seizure during the study.
In the full crossover analysis, which included all T25FW data from both treatment periods, there was a significant increase in walking speed while participants were taking dalfampridine-ER compared to placebo (p = 0.027). This treatment effect was further supported by separate analyses of the two treatment periods. In both treatment periods there was a greater average improvement in walking speed among participants receiving dalfampridine-ER. These were not statistically significant given the smaller number of measurements in each period compared to the overall analysis. The co plans to begin a Phase 2b/3 study, pending successful conclusion of a multi-dose, pharmacokinetic study of a once-a-day formulation of dalfampridine-ER, as well as discussions with the FDA.
