7:02AM Acorda Therapeutics present data showing long-term safety and tolerability of AMPYRA was consistent with that observed in clinical trials, with no new safety signals emerging (ACOR) 24.39 : Co presented data showing that the increase in walking speed demonstrated by people with multiple sclerosis (MS) who responded to treatment with AMPYRA during three-month Phase 3 clinical trials was also observed for up to five years in open-label extension studies. In addition, the long-term safety and tolerability of AMPYRA was consistent with that observed in clinical trials, with no new safety signals emerging. These data, from open-label extension studies of AMPYRA? (dalfampridine) Extended Release Tablets, 10 mg, were presented at the 64th American Academy of Neurology Meeting in New Orleans, LA. During the open-label extension, patients who were responsive to AMPYRA in the Phase 3 parent studies continued to show improvements in walking speed relative to non-responders for up to 5 years, which was the maximum drug exposure in the open-label studies. There was an overall decline in walking speed observed over the course of the extension studies in all patient groups, which is consistent with the natural MS disease progression that has been previously reported. Across the two extension studies, the most common adverse events were urinary tract infections, falls, MS relapses, arthralgia, and peripheral edema. There were four seizure-related adverse events reported in the extension studies among the patients who were treated with AMPYRA in the parent trial and subsequently enrolled in the extension (1.3%). Three of these events were convulsions, and one was a partial complex seizure. These rates are similar to reported seizure rates in the general MS population.
surf's up......crikey
