Acorda's Ampyra fails main goal of post-marketing study

(Reuters) - Acorda Therapeutics Inc said a post-marketing study of its multiple sclerosis drug Ampyra failed to meet the main trial goal of an improvement in patients' walking speed.

The 5 mg and 10 mg doses of Ampyra did not yield statistically significant results on the timed 25-foot walk test as compared with the placebo group, the company said.

Two patients, each from the 5 mg and 10 mg treatment group, experienced serious adverse events, including the loss of consciousness in the 10 mg group, Acorda said in a statement.

In July, the FDA had issued a warning to patients and physicians about the increased risk of seizures from the drug in multiple sclerosis patients with kidney impairment.

The drug, Ampyra, was approved for the dose strength of 10 mg by the U.S. Food and Drug Administration in January 2010 to improve walking ability in multiple sclerosis patients.

Multiple sclerosis is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and a loss of vision.

Ampyra had sales $66.3 million in the quarter ended June.

Acorda's marketing partner Biogen Idec Inc, which aims to sell Ampyra under the brand name Fampyra in Europe, received conditional approval for drug in Europe July last year.

Conditional approval is granted to drugs in which the benefit is seen to outweigh the risk but where additional information is needed to confirm that view.

Shares of the Ardsley, New York-based company closed at $21.72 on Friday on the Nasdaq.

(Reporting By Pallavi Ail in Bangalore; Editing by Sreejiraj Eluvangal)

Source: http://news.yahoo.com/acordas-ampyra-fails-main-goal-post-marketing-study-113858152--finance.html

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