7:04AM Acorda Therapeutics: AMPYRA two-year safety data presented at 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; 160 seizures were reported, or ~ 4.6 per 1000 patient-years of use (ACOR) 24.16 : Co announced safety data from more than 62,400 people with multiple sclerosis taking AMPYRA 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. 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.
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