LYON, FRANCE—The following news stories were originally written on site at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and posted on the Neurology Reviews website www.neurologyreviews.com. We have reproduced them here for readers who did not see our online conference reporting. More news from the ECTRIMS Congress can be found online and in upcoming issues of Neurology Reviews.
Postmarketing Safety Data Released for Ampyra (Dalfampridine)
Michele Jara, DSc, Director of Epidemiology at Accorda Therapeutics in Hawthorne, New Jersey, and colleagues presented the findings from a two-year safety study of Ampyra (dalfampridine) extended-release tablets (10 mg) indicated for the treatment of walking impairment in patients with multiple sclerosis (MS). Among the major findings, Dr. Jara reported that:
• The safety profile for Ampyra two years after FDA approval is similar to that observed in clinical trials.
• The most frequent associated adverse events were dizziness, insomnia, balance disorder, headache, nausea, urinary tract infection, back pain, and asthenia.
• Among the 62,400 patients prescribed Ampyra, the rate of seizure (4.6 per 1,000 patient-years of use) was comparable to that seen in the MS population overall. Length of treatment prior to seizure ranged from first dose to two years, with 20% of the seizures occurring within a week of starting treatment.
The analysis examined all postmarketing data that were reported to the drug maker (Acorda) and the FDA from March 2010 through March 2012.