FAMPYRA® (prolonged-release fampridine tablets) is a treatment indicated to improve walking in adult patients with multiple sclerosis (MS). Biogen Idec has a license from Acorda Therapeutics, Inc to develop and commercialize FAMPYRA in all markets outside the United States. In the U.S this prolonged-release fampridine tablet formulation was developed and is being commercialized by Acorda under the name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
FAMPYRA is the first treatment to address the unmet medical need of walking improvement in people living with MS demonstrating clinical efficacy in adults with MS. FAMPYRA can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs.
In clinical trials, patients responding to FAMPYRA had an average increase in walking speed of 25 percent and FAMPRYA was shown to provide a clinically meaningful improvement in walking.
The highest incidence of adverse reactions identified from placebo-controlled trials in MS patients with FAMPYRA, given at the recommended dose, was urinary tract infection (in approximately 12% of patients), although infection was often not proven by culture. Adverse drug reactions identified were mainly divided between neurological disorders, such as insomnia, balance disorder, dizziness, paraesthesia, headache and gastrointestinal disorders including nausea, dyspepsia and constipation. In post-marketing experience, there have been reports of seizure. Confounding factors may have contributed to the occurrence of seizure in some patients.