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WASHINGTON (AP) – Federal health regulators have approved an Acorda Therapeutics pill to improve walking in patients multiple sclerosis, an often disabling disease that affects the nervous system.
The Food and Drug Administration said Friday Ampyra is the first drug approved to help multiple sclerosis patients walk.
About 400,000 patients in the U.S. have the disease, which affects the brain and nervous system, causing loss of balance, muscle spasms and other movement problems.
Between 260,000 and 340,000 of those patients have difficulty walking, and could be eligible for the new drug, according to company officials.
Acorda, based in Hawthorne, N.Y., conducted two trials tracking patients’ ability to complete a 25-foot walking exercise. Both studies showed improvements in time needed to complete the exercise. While those gains were often just a fraction of a second, Acorda CEO Ron Cohen said that on average, patients’ times improved by 25 percent after taking Ampyra.
Cohen said the company will launch Ampyra in the U.S. in March. He added that the pill could be combined with older medications designed to slow the progression of multiple sclerosis.
Ampyra will be manufactured under a license with Irish drugmaker Elan Corp., which developed the extended-release formulation for the pill. Acorda will market and distribute the drug in the U.S.
Company shares jumped $2.50, or 9.8 percent, to close at $28.12 Friday, adding 13 cents in after-hours trading.
In its announcement posted online, the FDA warned that Ampyra can cause seizures when given at higher-than-recommended doses – anything over 10 mg. Company studies showed that doses above 10 mg increased seizure risk but did not increase the drug’s effectiveness.
The FDA said the drug should also not be given to patients with moderate to severe kidney disease, as they are at greater risk of seizures.
Other side effects reported in clinical trials included: insomnia, urinary tract infections, dizziness, headache, nausea and throat pain, according to the FDA.
(This version CORRECTS Corrects Acorda CEO last name to ‘Cohen’ throughout.)