Tuesday, August 14, 2012

Targeted failure of the week. No 11.

Yes – in that way: we have so many failures of a targeted approach that I plan to count it. I have already written about 10 failures (probably 20) since I started the blog, so this article will be No 11.
Ok, this time the failure concerning Ampyra: a potassium channel blocker approved in the US in 2010 as a treatment for improving walking in patients with MS.
However, the medicine can cause seizures, and as this risk increases the higher the dose, US regulators asked Acorda to investigate whether a 5mg twice daily version is as effective as the approved 10mg twice a day.
The four-week study randomised 430 participants to receive either placebo, or 5mg or 10mg of Ampyra twice daily.
Unfortunately, neither dose of the Acorda's drug showed a stastically-significant improvement in the primary endpoint - change in walking speed - compared with the placebo arm.
Well, simple structure – simple failure.

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