“In the statistical plan, a total of 364 patients would be required to obtain 90% power with a 30% allowance for drop out,” said Randall Kaye, vice president of Clinical and Medical Affairs for Avanir. “We have determined that it is unnecessary to enroll additional patients and now consider the trial fully enrolled with approximately 380 patients. The data from the trial is currently anticipated in mid-2007.”
The protocol for the phase III study was reviewed by the FDA through a special protocol assessment (SPA) process. An SPA is an agreement between the FDA and the sponsor of a clinical trial documenting that if the study endpoints are met, the results should be acceptable to support a new drug application. Assuming positive outcomes, Avanir currently expects to use the data from this study as one of the phase III clinical trials required before it would be able to submit a new drug application for this indication.
Painful diabetic neuropathy may affect more than 50% of patients with diabetes as their disease progresses, according to the American Diabetes Association.