DepoDur gets the nod for Australia
has been approved for marketing in Australia by the Therapeutic
Goods Administration.
DepoDur (morphine sulphate), already approved in the US and UK, will be marketed in Australia by Orphan Australia. Using Pacira's DepoFoam technology, DepoDur is a novel, single dose modified-release formulation of morphine and has been approved in Australia for relief of post-operative pain, following major orthopaedic, abdominal or pelvic surgery. Administration is via the lumbar epidural route, at a maximum recommended dose of 10mg. DepoDur can provide pain relief for up to 48 hours while removing the limitations associated with indwelling epidural catheters. "We are pleased to add an innovative product like DepoDur to our growing hospital product portfolio," Orphan Australia chief executive John Michailidis said in a statement. "It fits well with our philosophy of providing specialists with novel, highly specialised products which otherwise would not be available to the Australian market. We believe DepoDur will play an important role in managing post-operative pain in selected types of surgery." The DepoFoam drug delivery technology aims to address the limitations which are associated with traditional injectable delivery systems, such as side effects, maintaining drug concentrations, and cost. DepoFoam consists of many spherical, lipid-based particles between 10 and 40 micrometers in size. These are made up of nonconcentric internal aqueous chambers which contain the encapsulated drug. The "multivesicular liposome" is either composed of naturally occurring or synthetic analogues of common lipids. The drug is released over an extended period of time based on lipid composition and the reorganisation of the lipid membranes allowing diffusion of the drug, while the lipids are cleared naturally from the body. The DepoFoam system can be administered for either local or systemic drug delivery, under the skin, within muscle tissue, intraocular and into spinal fluid, joints and the abdominal cavity. "It has been demonstrated that small and large molecule compounds, including traditional pharmaceuticals, proteins, peptides, antisense oligonucleotides and DNA, can successfully be encapsulated into DepoFoam," according to the company.
