Previously referred to as DepoMorphine, DepoDur is a novel single dose sustained-release injectable formulation of morphine designed for the control of pain after major surgery.
SkyePharma expects that the drug’s main use will be in control of post-operative pain in hospitalized patients undergoing major surgical procedures requiring general or regional anesthesia, such as major abdominal surgery, orthopedic surgery and caesarean section. Currently, there are an estimated six million such procedures every year in the US and five million in Europe.
“We are delighted with the approval of DepoDur in the UK and are confident that this will lead to additional approvals in other European markets under the mutual recognition process,” said Frank Condella, chief executive of SkyePharma.
DepoDur was licensed to Zeneus for distribution in the EU. Recently, SkyePharma bought back the rights to the product and is now seeking a partner for the product in the EU.