By Karen Young

Durect Corp. began a Phase III trial for Chronogesic, its treatment for chronic pain.

The Cupertino, Calif.-based company said the primary objectives for the trial are to continue to demonstrate that the product is safe, that patients can be transitioned from use of a variety of existing opioids such as pills and patches to the use of Chronogesic, and that the product is effective and provides pain relief at least equivalent to the patient¿s existing pain therapy. Chronogesic is a three-month continuous-infusion subcutaneous implant.

Schond Greenway, director of investor relations, declined to provide specifics regarding the design of the Phase III trial, or projected time frames for completing it.

A recently finished Phase II study focused on measuring the potency of fentanyl, the active agent in Duragesic, as compared to sufentanil, the active agent in Chronogesic. Durect reported that results determined that sufentanil was 7.5 times more potent than fentanyl.

The initial focus of the Phase III trial is to confirm the method developed from the Phase II trial regarding how to transition patients from Duragesic to Chronogesic, the company said.

Greenway said that he could not reveal more about the Phase III trial due to discussions about commercialization partnering that the company has undertaken with Johnson & Johnson, of New Brunswick, N.J., which could handle the treatment in the U.S. and Canada. Those talks are the result of J&J¿s acquisition of Alza Corp., of Mountain View, Calif., earlier this year. Alza had an agreement with Durect by which it would have an exclusive option to be Durect¿s commercialization partner in the U.S. and Canada, Greenway said. (See BioWorld Today, March 28, 2001.)

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