March 16, 2009
Phase 2b study of Transdur-sufentanil patch for chronic painDurect Corporation announced positive results from a 74 patient Phase 2b clinical trial conducted by Endo Pharmaceuticals of Transdur-sufentanil, a proprietary seven day patch under development for the treatment of chronic pain. The Phase 2b trial was an open label, two-stage study to explore the titration (conversion) schedule for transitioning opioid-experienced patients with non-malignant moderate-to-severe chronic pain from current oral (eg, OxyContin) and transdermal opioid (eg, Duragesic) therapies to Transdur-sufentanil. After achieving an endpoint of adequate, stable pain control and an acceptable safety profile on Transdur-sufentanil, patients entered a 28-day continuous treatment maintenance period, followed by a 7-day follow-up period to ensure that an adequate pain control regimen was re-established. Approximately half (36 out of 74) of the screened patients successfully entered the maintenance period. This result is consistent with expectations for the study and with other chronic pain studies of a similar nature.
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