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Nefiracetam. Daiichi Seiyaku.
1GlaxoWellcome SpA, Pharmacology Dept, Verona, Italy. fc20377@GlaxoWellcome.co.uk
Current Opinion in Investigational Drugs (London, England : 2000)
|July 2, 2002
Summary
Nefiracetam, a drug for cerebrovascular disorders, showed insufficient efficacy in Japanese Phase III trials, leading to withdrawal of its NDA. Further development was halted due to efficacy concerns.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Trials
Background:
- Nefiracetam (DM-9384) is a cerebral metabolic enhancer developed by Daiichi.
- It was investigated for treating cognitive deficits following cerebrovascular events and dementia.
Purpose of the Study:
- To evaluate the efficacy of nefiracetam in patients with sequelae of cerebral infarction.
- To support regulatory filings for nefiracetam in Japan and the US.
Main Methods:
- Phase II trials conducted in the US for stroke and Alzheimer's dementia symptoms.
- Modified Phase III trials in Japan for patients with sequelae of cerebral infarction.
Main Results:
- Clinical trials in China were completed by August 2000.
- Daiichi withdrew its Japanese New Drug Application (NDA) in February 2002 due to insufficient efficacy in revised trials.
Conclusions:
- Nefiracetam demonstrated insufficient efficacy, leading to the discontinuation of its development for cerebrovascular disorders.
- The drug's potential launch in Japan and the US was ultimately halted.