Breaking News From Pharma & Bio Ingredients Subscribe via RSS Subscribe via RSS



SkyePharma Announces First European Approval of DepoDur


Posted on 2006-04-28 09:02:00



SkyePharma PLC announced today that the UK Medicines and Healthcare products Regulatory Agency ("MHRA") has approved SkyePharma's 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.

Frank Condella, Chief Executive of SkyePharma, said: "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 DepoDur represents another successful outcome resulting from the major commitment SkyePharma has made to product development, including funding the product through Phase III trials and building and on-going funding of a purpose-built manufacturing plant in San Diego, USA. 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.

"DepoDur was developed and is manufactured by SkyePharma Inc. the San Diego based injectable business, which SkyePharma has announced is in the process of being divested, "This approval, along with the availability of EU rights for DepoDur, provides further value to our injectable business."