The Food and Drug Administration has awarded orphan drugdesignation to Cambridge NeuroSciences Inc.'s pramiracetam asan adjunct to electroconvulsive therapy (ECT) in the treatmentof severe depression, the company said Monday.

Pramiracetam will enter Phase III testing by the first quarterof 1992. Results from Phase II trials are "encouraging," ElkanGamzu, company president and chief operating officer, toldBioWorld. "We have solid preclinical evidence that it blocks thememory effects of ECT," Gamzu said.

Memory losses of events just before and during ECT cancomplicate the treatment. Pramiracetam had been tested in thememory loss of Alzheimer's disease and was found ineffective,yet the animal model that predicted its usefulness as a memoryaid was much more relevant to the disruption that occurs withECT, Gamzu said.

Pramiracetam would be given twice daily for the month oftherapy with electroshock that is used to treat severedepression. The company has already started to manufacturethe drug in tablet form.

The Cambridge, Mass., company in April acquired the rights todevelop and market pramiracetam from Warner-Lambert Co.,which will receive royalties if the drug reaches the market. Thecompany had paid to continue the Phase II trials sponsored byWarner-Lambert.

More than 100,000 courses of electroconvulsive shock therapyare prescribed each year in the United States.

Cambridge NeuroScience's stock (NASDAQ:CNSI) picked up 25cents to close at $12.75 Monday.

-- Roberta Friedman, Ph.D. Special to BioWorld

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