Durect reports positive data from Phase IIb pain trial

Durect, a specialty pharmaceutical company, has announced positive results from a 74 patient Phase IIb clinical trial conducted by Endo Pharmaceuticals of Transdur-sufentanil, a seven day patch under development for the treatment of chronic pain.

The Transdur-sufentanil Phase IIb clinical 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

In this study, approximately half (36 out of 74) of the screened patients successfully entered the maintenance period, which is consistent with expectations for the study and with other chronic pain studies of a similar nature. After exploring multiple dose titration regimens, two acceptable dose titration intervals have achieved the desired analgesic effect and side-effect profile, and therefore are expected to be utilized in Phase III, the company said.

James Brown, president and CEO of Durect, said: In this trial, all of the primary and secondary objectives were met by showing patients could be successfully converted from oral opioids such as OxyContin and from fentanyl patches such as Duragesic to Transdur-sufentanil, while also showing a reduction in pain scores on our therapy. We believe that our small, patient-friendly seven day sufentanil patch would compete effectively in the chronic pain market including both patches and oral opioids.