Saturday, May 29, 2010

Low Effectiveness And High Cost Mar Ampyra Release

The first and only oral drug intended to improve walking in multiple sclerosis patients, Ampyra, was approved by the FDA in January. The maker of the drug, Acorda Theraputics, claims that the drug is very effective. Ampyra has seen steady sales since it was released, but there are questions about its effectiveness.

How Ampyra is used

The brand name for Fampridine sustained release pills is Ampyra. The drug works by blocking some potassium receptors, which restores impulses between nerves. MS patients were not the original target of Ampyra – it was first studied for use with spinal cord injuries. 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?

The uses of Ampyra

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. Doses that mimic a sustained release were used in the studies used to get the drug approved. Ampyra in the United States is sold as a single-dose, sustained-release drug. Ampyra is intended to be used as an “additional” treatment, in conjunction with other MS drugs.

The numerical effectiveness of Ampyra

The percentages behind Ampyra’s effectiveness are statistically significant- but only by the slimmest of margins. The group of patients in the double-blind study taking the drug in Ampyra did improve their walking speed. Patients were able to walk 25 feet between half and .88 seconds more quickly. The possible significance of this improvement is just barely above chance and placebo effect. If a MS patient’s condition is declining, though, even that half-second or more improvement could be helpful.

The side effects of Ampyra

Ampyra’s side effects notice is quite large. Infections, dizziness, and insomnia are all reported between nine and fifteen percent of the time. The Ampyra patients also tended to relapse at twice the rate of placebo patients. Fampridine can cause severe seizures in humans, as it was originally developed as a bird poison.

Sales of Ampyra

Ampyra sold about $ 3.4 million in the first few months it was on the market. The first packages of the drug were sent to pharmacies on March 1. Between March 1 and April 29, approximately 2,000 prescriptions for Ampyra were written. The real question, though, is whether the dangers, health care costs and side effects of Ampyra are worth the 35 percent chance of walking 25 feet one second faster.



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