AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg

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On January 22, 2010, the U.S. Food and Drug Administration (FDA) approved AMPYRA (dalfampridine) Extended Release Tablets, 10 mg. AMPYRA is indicated as a treatment to improve walking in patients with MS. This was demonstrated by an increase in walking speed.

The approval of AMPYRA was the culmination of over 20 years of work involving hundreds of scientists, physicians and other healthcare professionals, and more than 2,000 patient volunteers.

More than 400,000 people in the U.S. and nearly 2.5 million people worldwide are living with MS. For many people living with MS, the disease affects their ability to walk. In a 2008 Harris Interactive survey of people living with MS co-sponsored by Acorda and the National MS Society, almost two thirds reported having walking impairment, and of that group 70% indentified walking impairment to be the most challenging aspect of their MS. Aside from statistics and research, we heard from people with MS, their caregivers and families, that improving walking ability would have a meaningful impact for them.

AMPYRA is the first MS therapy that specifically addresses walking impairment. We are gratified to have made a contribution to improving the care of people with MS. For more information about AMPYRA, please review the press release or visit www.ampyra.com.

Important Safety Information

Do not take AMPYRA if you:

  • have ever had a seizure
  • have certain types of kidney problems

Do not take AMPYRA together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine, fampridine).

AMPYRA can cause seizures. Your chance of having a seizure is higher if you take too much AMPYRA or if you have kidney problems. Before taking AMPYRA tell your doctor if you have kidney problems. Stop taking AMPYRA and call your doctor right away if you have a seizure while taking AMPYRA.

AMPYRA may cause serious side effects, including kidney or bladder infections.

The most common side effects of AMPYRA include: urinary tract infection; trouble sleeping (insomnia); dizziness; headache; nausea; weakness; back pain; problems with balance; multiple sclerosis relapse; burning, tingling or itching of your skin; irritation in your nose and throat; constipation; indigestion; pain in your throat.

Take AMPYRA exactly as your doctor tells you to take it. Do not change your dose of AMPYRA.

Take one tablet of AMPYRA 2 times each day about 12 hours apart. Do not take more than 2 tablets of AMPYRA in a 24-hour period.

Take AMPYRA tablets whole. Do not break, crush, chew or dissolve AMPYRA tablets before swallowing. AMPYRA is released slowly over time. If the tablet is broken, the medicine may be released too fast. This can raise your chance of having a seizure.

If you miss a dose of AMPYRA, do not make up the missed dose. Do not take 2 doses at the same time. Take your next dose at your regular scheduled time. If you take too much AMPYRA, call your doctor or go to the nearest hospital emergency room right away.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby.

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if AMPYRA passes into your breast milk. You should not breast-feed while you are on AMPYRA.

It is not known if AMPYRA is safe and effective in children less than 18 years of age.

For full Prescribing Information and Medication Guide, please visit: www.AMPYRA.com.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/, or call 1-800-FDA-1088.

AMPYRA® is a registered trademark of Acorda Therapeutics, Inc. AMPYRA® is marketed by Acorda Therapeutics, Inc. and is manufactured under license from Elan Pharma International Ltd.