FDA Panel: New MS Drug Helps Walking
Ampriva Helps Improve Nervous System Function in Multiple Sclerosis Patients
By
Daniel J. DeNoon
WebMD Health News
Reviewed By
Louise Chang, MD
Oct. 16, 2009 -- A new drug for multiple sclerosis truly helps some patients
walk better, says an FDA advisory panel.
The finding, by a panel of outside experts, makes it more likely that full
FDA approval will come soon. If approved, the drug -- tentatively named Ampriva
-- would be the first to improve nervous system function in people suffering
from the devastating disease.
Current treatments slow MS progression and target symptoms, but they do not
affect the damage the disease already has done. Nerves frayed of their
protective myelin sheath lose their ability to send electrical signals. Ampriva
improves conduction of nerve signals.
Nerve damage from MS often makes it very difficult for patients to walk.
It's among the symptoms that most bother people with MS.
In clinical trials, over 35% of MS patients taking Ampriva were able to walk
faster, says Andrew D. Goodman, MD, director of the multiple sclerosis center
at the University of Rochester and the lead investigator in the clinical
studies.
"Those who responded improved walking speed on average by 25%," Goodman
tells WebMD. "This can mean things like getting to the bathroom on time before
having an accident, or getting across the street before the light changes."
Ampriva is not a miracle cure. While it can help even patients with
relentlessly progressive MS, patients do continue to get worse over time. And
the improvements seen with the drug are rather modest. In fact, the central
question the advisory panel was asked to decide was whether the improvements
were truly significant to patients.
At the hearing, people with MS and their family members told the panel that
they would welcome the kind of improvements seen in the clinical trials.
Goodman says he hears the same thing from his patients.
"The kinds of things that people have described to me are, 'Look, I can get
around the supermarket without having to hold on to the cart all the time,' or
'Just getting up that step between the garage and the house gives me
independence,'" he says.
The drug is by no means risk-free. Ampriva is a new formulation of a drug
called fampridine, which was originally used as a bird poison.
Some 20 years ago, test tube studies suggested that fampridine could improve
nerve conduction. Since then, some neurologists -- Goodman is not one of them
-- have ordered the drug from compounding pharmacies for their MS patients.
Fampridine causes seizures and convulsions at doses not much higher than the
dose thought to be therapeutic. The sustained-release formulation of fampridine
used in Ampriva lessens the chance of this side effect, but the drug cannot be
used by MS patients with a history of seizures.
The FDA advisory panel voted 10-2, with one abstention, that -- for some MS
patients -- they would consider the benefits of Ampriva to outweigh the
risks.
The FDA is scheduled to consider Acorda Therapeutics' application for
approval of Ampriva next week, although that schedule is not set in stone.
Acorda had intended to call the drug Amaya, but the FDA rejected that brand
name.
SOURCES: Email from Karen Mahoney, spokeswoman Acorda Therapeutics.
News release, Acorda Therapeutics.
FDA Advisory Committee briefing documents, accessed online Oct. 16, 2009.
WebMD Health News: "Experimental MS Drug May Aid Walking."
Andrew D. Goodman, MD, professor of neurology; director, Multiple Sclerosis Center; chief, Neuroimmunology Unit, University of Rochester Medical Center, N.Y.
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