Acorda Therapeutics got some good news with its post-marketing Ampyra study: The lower, less-valuable 5 mg dose didn't improve multiple sclerosis patients' walking ability any better than placebo. But neither did the FDA-approved 10 mg dose, at least not in any statistically significant way.
The company hastened to point out that the walking test used in this trial--a 25-foot timed assessment--differed from the walking assessment used in previous studies. Placebo response was stronger than usual. And the latest study included a wider variety of patients, CMO Enrique Carrazana said in a statement, which could help explain the 10 mg dose's failure.
Plus, Carrazana said, the 10 mg dose did beat placebo for the latest study's secondary endpoint, a 6-minute walking test.
The FDA had asked Acorda to study the lower dose because the 10 mg twice-daily pill caused seizures in some patients, Dow Jones points out. The agency warned last month about the seizure risk in patients with poor kidney function.
In terms of side effects, one patient from each arm of the study experienced serious adverse events, the company said. "We believe the current study, together with the Ampyra registration studies, continue to show that 10 mg twice daily is the appropriate, safe and effective dose," Carrazana said.
What the study might do for--or against--Ampyra's sales remains to be seen. Together with the FDA's concerns, a failure to best placebo could turn doctors away from the drug, which focuses on dealing with an MS symptom--walking ability--rather than the disease course itself. Meanwhile, partner Biogen Idec ($BIIB) is waiting for final and full approval for the drug in Europe, where it's sold under the brand name Fampyra.
- read the Acorda statement
- get more from Dow Jones
- see the FierceBiotech story
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