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Phase 2 Study Initiated for Sufentanil Patch
"The initiation of the Phase II program for the TRANSDUR-Sufentanil patch is an important milestone for us. We have been able to move this program rapidly from Phase I in October 2004, in part due to our Phase II and dose conversion data from our clinical studies with our CHRONOGESIC(R) product," said James E. Brown, DURECT's President and CEO. "Our previous experience with the systemic delivery of sufentanil in approximately 100 patients with CHRONOGESIC is directly applicable to the development of our TRANSDUR-Sufentanil patch."
Phase II Program
The objectives of the Phase II program are to evaluate the pharmacokinetics, efficacy, and safety of repetitive applications of our sufentanil patch in chronic pain patients for a period of up to four weeks.
DURECT's TRANSDUR-based transdermal sufentanil product is intended to provide extended chronic pain relief for up to seven days, as compared to the three days of relief provided with currently available opioid patches. Further, we anticipate that the small size of our sufentanil patch (potentially as small as 1/5th the size of currently marketed transdermal fentanyl patches for a therapeutically equivalent dose) may offer improved convenience for patients. Worldwide sales for DURAGESIC(R), a leading transdermal fentanyl product, exceeded $2.1 billion in 2004.
Source: Durect Corporation