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Company Releases ‘Real World’ Safety Data for Ampyra (Dalfampridine) in Multiple Sclerosis
Two-year safety similar to that seen in clinical trials (Oct. 10)
On October 10, Acorda Therapeutics, Inc., based in Ardsley, N.Y., announced safety data from more than 62,400 patients with multiple sclerosis (MS) taking Ampyra (dalfampridine) extended-release tablets, 10 mg, during the first 2 years of availability in the U.S. The data show that the safety profile of Ampyra is similar to that observed in clinical trials.
The analysis examined all post-marketing adverse events (AEs) that were reported to Acorda and the FDA from March 2010 through March 2012. Key findings included:
- Among the 62,400 patients who were prescribed Ampyra during the first 2 years following FDA approval, 160 seizures were reported, or approximately 4.6 per 1,000 patient-years of use. This rate is comparable with the rate of seizure seen in the overall MS population. Length of treatment prior to a seizure ranged from the first dose to 2 years, with 20% of the seizures occurring within 1 week of starting treatment. Because of their disease, people with MS are at a higher risk of seizure than are people who do not have MS.
- The most frequently reported AEs from March 2010 through March 2012 were dizziness, insomnia, balance disorder, headache, nausea, urinary-tract infection, back pain, and asthenia. These events are similar to the most frequently reported AEs during clinical trials of Ampyra.
The new analysis will be presented as a poster at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which will be held in Lyon, France, on October 10–13.
Ampyra is known as Fampyra in markets outside the U.S.
For more information, visit the Acorda Therapeutics Web site.