ADVERTISEMENT

On-Site Conference Reporting

ECTRIMS 2012 —Postmarketing Safety Data Released for Ampyra (Dalfampridine)

LYON, FRANCE—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.


Glenn S. Williams

 



ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT

Breaking News

More Headlines