FDA: NO PHASE III CLINICAL TRIAL FOR SURGICAL SPRAY

ZymoGenetics said the FDA has informed the company that it will not be required to conduct an additional Phase III clinical trial of its recombinant human Thrombin (rhThrombin), which aids in controlling bleeding during surgery.

The company completed a Phase III trial of rhThrombin using a different administration method last fall, spokeswoman Susan Specht said. In that trial, the rhThrombin, which is not derived from animal or human blood, was applied to patients using a gel foam sponge.

The company has also been running a Phase II trial of the substance using a spray delivery system on patients requiring skin grafts for burns and traumatic injuries. That trial started last August and is expected to be completed in the second quarter of this year.

ZymoGenetics expects that skipping the Phase III spray trial will save it money and allow it to offer the product approximately 18 months earlier than expected, President and CEO Bruce Carter said.

The company said it still must submit prior approval supplements after its biologics license application for rhThrombin is approved.