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12:00 AM
 | 
Apr 18, 2005
 |  BioCentury  |  Product Development

Neuro3d: The wait begins

Marketed schizophrenia drugs have met the efficacy test, but also have side effects and safety issues, including QTc prolongation, weight gain and extrapyramidal symptoms. Based on Phase II data, Neuro3d SA says its ocaperidone doesn't appear to cause weight gain, although it is too soon to tell about QTc. As the company gears up to start Phase III trials in the first quarter of 2006, partner Johnson & Johnson is weighing whether or not to exercise its option to reacquire rights to the product.

"When you talk with regulatory authorities and psychiatrists, they are not looking for more efficacious compounds," said CEO Charles Woler. "The safety and metabolic issues are the critical problems today."

Last week, Neuro3d (Mulhouse, France) said ocaperidone met the primary endpoints in two double-blind, international Phase II trials to treat schizophrenia (see B13).Preliminary data from an eight-week, placebo-controlled Phase II trial (OCA-05) in 127 patients showed that the atypical antipsychotic significantly improved...

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