sNDA for Alzheimer's drug

19-Nov-2004

Neurobiological Technologies, from Richmond, CA, US, reports that the FDA has accepted Forest Laboratories\' filing of a supplemental New Drug Application (sNDA) that would expand the indication of Namenda (memantine HCl) to include treatment for mild Alzheimer\'s Disease.

Neurobiological Technologies, from Richmond, CA, US, reports that the FDA has accepted Forest Laboratories' filing of a supplemental New Drug Application (sNDA) that would expand the indication of Namenda (memantine HCl) to include treatment for mild Alzheimer's Disease.

Currently, Namenda is indicated for moderate and severe forms of the disease and should the FDA approve the application, it would be the first drug approved in the US to treat all stages of Alzheimer's disease.

Paul Freiman, president and ceo, stated: 'Forest Laboratories' filing has the potential to expand demand for Namenda by increasing the number of patients whose doctors could prescribe it for the early treatment of Alzheimer's disease. We believe that early treatment is likely to provide greater benefits to patients.'

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Memantine received approval for the treatment of Alzheimer's disease in Europe in 2002 and in the US in 2003. In Europe, memantine has been marketed by Merz & Co. for a number of indications for several years. For Alzheimer's disease, memantine is now being sold by Merz's European marketing partner, H. Lundbeck. In the US, memantine is currently being sold by Forest Laboratories for moderate-to-severe Alzheimer's disease under the brand name Namenda. Under an exclusive marketing agreement, NTI receives royalty payments by Merz and its marketing partners from sales of memantine for Alzheimer's disease. Forest Laboratories is also evaluating Namenda for the treatment of neuropathic pain and is currently conducting Phase IIB/III human clinical studies.

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