Saturday, May 29, 2010

Ampyra Release Marred By High Cost And Low Effectiveness

The first drug designed to help MS patients improve their ability to walk, Ampyra received FDA approval early this year. Acorda Therapeutics, the maker of the drug, has presented numerous studies about the effectiveness of Ampyra. The effectiveness of Ampyra has been questioned both before and after its release into the general U.S. market.

The uses of Ampyra

Ampyra is a sustained-release Fampridine SR pill. The drug works by blocking some potassium receptors, which restores impulses between nerves. Though Ampyra has been studied for spinal cord injuries, it has been approved to help patients with Multiple Sclerosis walk more easily and more quickly. Depending on the insurance a patient may or may not have, Ampyra could cost up to $ 15,000 per year. That is a cost that goes above and beyond the no faxing payday loans many patients could qualify for – so what are the risks and rewards of the drug?

What Ampyra is used for

Ampyra is a drug that has shown to help improve walking speed in MS patients. Ampyra works for only about thirty-five percent of patients who take it. The original studies used by Acorda Theraputics to get the drug approved relied on twice-a-day doses. Ampyra in the United States is sold as a single-dose, sustained-release drug. Ampyra is supposed to be taken in addition to other MS drugs that treat symptoms.

The numbers behind Ampyra

While studies have shown that Ampyra is effective, the percentages in the study appear to be only barely statistically significant. The patients who took Ampyra in the study did improve their walking speed by a bit. Patients were able to walk 25 feet between half and .88 seconds more quickly. The statistical significance of this change is just barely above chance. For MS patients that may be declining, though, that improvement could be very helpful.

Dangers of Ampyra

Ampyra is sold with significant side effect warnings. Infections, dizziness, and insomnia are all reported between nine and fifteen percent of the time. Patients taking Ampyra also reported relapses in symptoms almost twice as often as patients taking a placebo. The drug in Ampyra, Fampridine, is actually a bird poison that can cause severe human seizures.

Sales of Ampyra

In the first quarter that Ampyra was FDA-approved for sales in the United States, Acordia reported $ 3.4 million in sales. On March 1, Acordia sent the first Ampyra to pharmacies. About 2,000 prescriptions for Ampyra were written between March 1 and April 29. Many patients are now wondering if the health care costs of Ampyra are, on balance, worth the 35 percent chance they might walk a tiny bit faster.



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