Each week, I receive questions about Ampyra, the medication that was approved in early 2010 to help people with MS to walk better.
HERE, are the top two questions I receive, then followed by questions asked to the AMPYRA® team:
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2 comments:
My husband takes the compound 4-aminopyridine. It is helping him much. He is wheelchair bound and cannot stand for longer than a few seconds at a time. but it has helped him to continue to function at the same level and not progress worse. We find this out whenever we do not get the refill in time and he has to go 3-4 days without it: his body ceases to function and he becomes nursing home material. thank God for this med! We asked our neurologist about Ampyra, since it is the approved form of aminopyridine, and he told us that if this is helping him so well, then there's no need to switch over to Ampyra; especially since it is much cheaper and this time and our insurance pays for about 60% of its cost. I highly recommend this drug and would also insist that MS patients try Ampyra if they can find a way to pay for it. Its well worth the effort!
Acorda Therapeutics nor lead study investigators (all of them!) would cooperate with me – or offer their perspectives – on the merits of global self-scoring metrics or hard endpoint data, such as improvement in walking speed, in assessing the new oral Ampyra. An Acorda spokesman did comment that the company preferred NOT to work with me, citing past “conclusions contrary to the preferred image" for Ampyra. Consequently, I welcome hearing directly from MS patients and prescribers directly to assess “how beneficial” Ampyra truly is for you – the ones that matter. ~ David J Phillips
Acorda VP Sabella told analysts on the third-quarter 2010 earnings call “approximately 75 percent of commercially-insured MS patients had no – or limited – prior authorizations (PAs).” Only an estimated five-percent of such patients are totally blocked from receiving drug reimbursement, said Sabella. Are PAs an issue for MS patients looking to start therapy?
As of September 30, management said the rate of “first refill” was 67 percent. How many of you folks are still on Ampyra for more than 30 days?
It is on the issue of “hard endpoints” where Acorda and I diverge sharply. In the longer of two extension studies, many responders have begun to demonstrate decreases in walking speed over time. (Remember, the drug doesn’t address the pathophysiology of the disease!)
Acorda likes talking about impressive 35 percent improvements in walking assessment scores, such as the length of time it takes for patients to complete a 25-foot course. What management doesn’t like to bring up is that in regulatory meetings with the FDA, committee members expressed concerns about the sponsor’s primary endpoints and the magnitude of improvement in the actual decreases in walking times for Ampyra-treated patients: differences of only 0.5 second and 0.88 seconds in its two pivotal trials. How many of you are “feeling better” the longer you stay on Ampyra – and how significant (in seconds) is your increase in walking speed or leg strength?
Contact: http://www.bnet.com/blog/sec-filings/acorda-8217s-ms-drug-ampyra-looks-good-now-but-that-probably-won-8217t-last/646
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