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CAMBRIDGE NEUROSCIENCE AWARDED ORPHAN DRUG STATUS FOR PRAMIRACETAM; PHASE III TRIALS TO BEGIN IN 1992

CAMBRIDGE NEUROSCIENCE AWARDED ORPHAN DRUG STATUS FOR PRAMIRACETAM;
 PHASE III TRIALS TO BEGIN IN 1992
 CAMBRIDGE, Mass., Nov. 11 /PRNewswire/ -- Cambridge NeuroScience, Inc. (NASDAQ: CNSI) announced today that its psychiatric product, pramiracetam, has been designated by the Food and Drug Administration as an orphan drug for the management of cognitive dysfunction and enhancement of antidepressant activity associated with the electroconvulsive therapy (ECT) for the treatment of severe depression. This designation gives the company the exclusive right to market the drug for this indication in the United States for seven years following regulatory approval. Pramiracetam will soon be entering Phase III trials in the United States.
 Cambridge NeuroScience holds an FDA-approved IND for pramiracetam. The company estimates that more than 100,000 courses of ECT are given each year in the United States, primarily in hospital settings. Pramiracetam would be administered twice daily for the approximately 30 days of each course of ECT. Cambridge NeuroScience acquired the development and marketing rights to pramiracetam for the United States and other markets from Warner-Lambert Company earlier this year.
 "We submitted a Phase III protocol to the Neuropharmacology Division of the FDA last week," said Elkan Gamzu, Ph.D., CNS president. "We have selected the clinical sites, and begun the manufacture of tablets, and we expect to initiate trials in the first quarter 1992," he added.
 Cambridge NeuroScience is a leading neuroscience company engaged in the discovery and development of prorietary pharmaceutical products to treat a variety of severe neurological and psychiatric disorders. The company's product development efforts are focused in three areas: neuroprotective compounds for the treatment of acute neurological disorders, such as stroke and traumatic brain injury; novel antipsychotic compounds for the treatment of mental illnesses such as schizophrenia; and growth factors for the treatment of neurodegenerative diseases such as diabetic peripheral neuropathies and ALS.
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 /CONTACT: Elkan Gamzu, Ph.D., president and COO of Cambridge NeuroScience, Inc., 617-225-0600; or Marcia A. Kean, executive V.P. of Feinstein Partners, Inc., 617-577-8110, for Cambridge NeuroScience/ (CNSI) CO: Cambridge NeuroScience ST: Massachusetts IN: MTC SU: DD-KM -- NE005 -- 2962 11/11/91 10:33 EST
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Publication:PR Newswire
Date:Nov 11, 1991
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