SkyePharma PLC and Endo Pharmaceuticals announced that the US Food & Drug Administration (FDA) has approved SkyePharma's New Drug Application (NDA) for DepoDur for the treatment of pain following major surgery. Previously referred to as DepoMorphine, DepoDur is a novel single dose sustained-release injectable formulation of morphine.
Michael Ashton, chief executive of SkyePharma, said: 'The FDA's decision to approve DepoDur is a tremendous vindication of our faith in the product. DepoDur represents the largest single commitment SkyePharma has made to product development, including funding the product through Phase III trials and building and sustaining a purpose-built manufacturing plant. We expect its commercialisation to have a profound effect on the company's future. Our clinical trial programme for DepoDur involved over 1000 patients in four different pain models and demonstrated the great potential of the product to improve the control of post-operative pain. We and our partners look forward to the benefits this product will bring for many patients after surgery.'
Endo's chairman and chief executive officer Carol A. Ammon said: 'We are delighted with the FDA's decision on DepoDur. We believe the approval of DepoDur is an important step in fulfilling our vision of building our franchise in pain management as well as extending our reach into complementary therapeutic areas such as anaesthesiology.'
She added that Endo expects to be in a position to commercialize DepoDur by the end of 2004 provided SkyePharma is able to provide sufficient inventory to support the launch of the product. 'We look forward to the commercialization of DepoDur and believe it provides a novel approach to the treatment of post-operative pain benefiting patients undergoing major surgery.'