The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS).
In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.
Multiple sclerosis is a chronic, often disabling, disease that affects the central nervous system, the brain, spinal cord, and optic nerves. There are about 400,000 people in the United States and 2.5 million people world-wide with MS.
The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. About half of all people with MS experience cognitive impairments like difficulties in concentration, attention, memory, and judgment, although these symptoms are usually mild and are frequently overlooked. Depression also is common among MS patients.
"Trouble with walking is one of the most debilitating problems people with MS face," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
Ampyra, when given at doses greater than that recommended (10 milligrams twice a day), can cause seizures. The most common adverse reactions reported by patients taking Ampyra in clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling or itching of skin.
Ampyra should not be used in patients with moderate to severe kidney disease. In these patients, blood levels with the drug approach those associated with the occurrence of seizures.
Ampyra will be manufactured under licenses from Elan of Dublin, Ireland, and distributed by Acorda Therapeutics Inc. of Hawthorne, N.Y.
UPDATE: 2012 - 10 -10
AMPYRA Two-Year Safety Data Presented at 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Two-year data from more than 62,400 people with multiple sclerosis highlight AMPYRA safety profile
Acorda Therapeutics, Inc. 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 28th 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."
This poster presentation was sponsored by Acorda Therapeutics, Inc. In markets outside of the United States, AMPYRA is available as FAMPYRA. FAMPYRA is being developed and commercialized by Biogen Idec in these markets based on a licensing agreement with Acorda.
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