April 27, 2005

New Negative Symptoms Drugs

Prestwick Pharmaceuticals Inc. a Washington, DC company that is developing a new drug for treatment of tardive dyskinesia, another drug called "D-Serine" for the treatment of the negative symptoms of schizophrenia - has announced that they have filed for an initial public offering to raise an estimated $ 74.8 million in preparation for the potential launch of its dopamine depletor, tetrabenazine.

Prestwick said it received fast-track designation for tetrabenazine, and if the New Drug Application (NDA) is filed this quarter, the company would be eligible for FDA approval as early as the first quarter of 2006. The company licensed rights to develop and commercialize tetrabenazine, a selective and reversible dopamine depletor, from UK-based Cambridge Laboratories Ltd. The product is marketed by Prestwick in Canada under the brand name Nitoman and by Cambridge Laboratories in Europe under the brand Xenazine.

The company also received what is termed by the FDA "orphan drug status" (which means that it addresses a relatively small market or number of people) for tetrabenazine in a second movement disorder, tardive dyskinesia, and is planning a Phase III trial in that indication.

The company also plans to file with the FDA an Investigation for New Drug (IND) this year for its schizophrenia drug, D-Serine, a selective amino acid co-agonist (enhancer). A Phase IIb trial is anticipated to begin next year.

More information on new schizophrenia drugs in development

Source of information:
Prestwick Pharmaceuticals, Inc.


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