Fourth time lucky?

Interneuron Pharmaceuticals Inc. believes it has learned its lesson from the failure of a 100-patient Phase III trial of CerAxon citicoline to treat stroke, which led the company to withdraw its NDA with the FDA last April. IPIC has designed a Phase III study that it hopes will avoid past problems by increasing the number of patients and dose of the compound, controlling enrollment to avoid a high placebo response, and using a rating scale that is best able to demonstrate a treatment benefit.

"We have learned a great deal about how to conduct stroke trials, the patient population most likely to benefit and rating scales of functional improvement that are most relevant," said President and CEO Glenn Cooper...