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Ampyra is First Symptom Management Drug Developed Specifically to Treat MS, the First Oral MS Therapy Approved for MS, and the First New FDA Approved Therapy to Come Through the MS Pipeline Since 2004
Date:1/23/2010

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Q. How is Ampyra taken?

A.  In clinical trials, participants on active therapy took one tablet of the drug by mouth two times per day. According to a company press release, Ampyra will be taken two times a day, approximately 12 hours apart.

Q. When and how will Ampyra become available for prescription?

A. According to the sponsor, Ampyra will be ready for prescription in March 2010. The drug will be distributed through a network of specialty pharmacies and coordinated by a team providing support services to facilitate access to the drug for patients and healthcare providers.

Q. Who might benefit from taking Ampyra?

A. There is no way of knowing in advance whether any particular individual who has MS might benefit from taking Ampyra. In clinical trials, a proportion of people with all types of MS were found to benefit in terms of walking speed. This proportion ranged from 35% to 43% of those who took the drug in the two phase III clinical trials.

Q. Can anyone with MS take Ampyra?

A. Ampyra was approved for persons with any type of multiple sclerosis. However, the FDA's approval of Ampyra comes with the warning that the drug should NOT be taken by individuals with a history of seizures, or by those with moderate to severe renal impairment (CrCl 51–80 mL/min).

Q. What is renal impairment, and why is it important that those taking AMPYRA have normal renal function?

A. "Renal" refers to the kidneys, which in essence clean the blood. If a person has adequate kidney function, then Ampyra will be cleared from the blood to a sufficient  between doses so as to maintain a steady drug level in the blood. If a person has moderate to severe kidney impairment, then there is a danger that the concentration of the drug will increase in the blood beyond the amount
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SOURCE National Multiple Sclerosis Society
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