Friday, January 29, 2010

Do Fifty CentiSeconds Justify Acorda Therapeutics' Oral MS Drug Approval by FDA?

Central to the Peripheral and CNS Drugs Advisory Committee’s review of Acorda Therapeutic’s (ACOR-$27.56) oral MS treatment Ampyra was whether the improvements seen with the drug were truly significant to patients. Wishful desires aside, MS patients and their family members would be prudent to carefully take it upon themselves to thoroughly peruse the entire contents of the 177 pages of the Fampridine SR background information and clinical trial data given to health regulators for review.

Drilling down into the data, one uncovers that the walking speed change favored the Fampridine group by just 0.88 seconds (to complete the 25-foot walk) in the first study (MS-F203) and by a scant 0.5 - second difference in the second pivotal trial (MS-F204). Are these meaningful enough improvements to justify a (likely) $10,000 price tag for one year of treatment?
Read More….

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

1 comment:

persephone1 said...

Over and over people with little or no knowledge of MS weigh in with judgments that question the effectiveness of such "small" walking speed improvements. If you bothered to really read about the disease and the drug, it's not just walking that improves. When neurological signals get through thanks to this drug, everything improves: vision, balance, stability, cognition, muscle strength, and--yes--walking coordination and speed. You betray your ignorance both about the disease and the drug when you make statements like this. I participated in a 2-year trial for Ampyra and my life changed so much for the better that I will happily take this drug for the rest of my life. Until they find a cure for MS, this is a wonderful solution for improved functioning.