Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced safety data from more than 62,400 people with multiple sclerosis (MS) taking AMPYRA (dalfampridine) Extended Release Tablets, 10 mg during the first two years of availability in the United States. The data showed that the safety profile of AMPYRA is similar to that observed in clinical trials.
This analysis was presented at the 28 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held in Lyon, France from October 10-13. AMPYRA is known as prolonged-, modified, or sustained-release fampridine (FAMPYRA ®) in some countries outside the United States.
The analysis examined all post-marketing adverse events (AEs) that were reported to Acorda and the U.S. Food and Drug Administration (FDA) from March 2010 through March 2012. As is typical in post-marking data collection, there is a potential for underreporting of AEs. Key findings included:
- Among the 62,400 patients who were prescribed AMPYRA during the first two years following FDA approval, 160 seizures were reported, or approximately 4.6 per 1000 patient-years of use. This rate is comparable to the rate of seizure seen in the overall MS population. Length of treatment prior to a seizure ranged from first dose to two years, with 20% of the seizures occurring within a week of starting treatment. Because of their disease, people with MS are at a higher risk of seizure than 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 are similar to the AEs most frequently reported during AMPYRA clinical trials.
“AMPYRA has been available for over two years in the United States, providing us with safety data from real-world use by people with MS. These data showed that the safety profile of AMPYRA in clinical practice is consistent with what was observed in clinical trials,” said Enrique Carrazana, M.D., Acorda Therapeutics’ Chief Medical Officer. “The data also indicate the rate of seizure has remained consistent over time, and is within the range that is expected in the overall MS population.”