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news.Following positive phase I trial results, California's Durect Corporation has initiated a phase II program for its Transdur-based sufentanil patch in chronic pain patients.
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The objectives of the phase II program are to evaluate the pharmacokinetics, efficacy, and safety of repetitive applications of Durect’s sufentanil patch in chronic pain patients for a period of up to four weeks.
The 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.
The company’s phase I trial for the Transdur-Sufentanil patch showed good safety, tolerability and drug release for up to seven days.
“The initiation of the phase II program for the Transdur-Sufentanil patch is an important milestone for us,” said James Brown, Durect’s president and CEO. “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 product.”