Orphan Australia Pty Ltd receives registration approval for the new dose form DepoDur®, Pacira’s modified release injection of morphine sulfate
Pacira Pharmaceuticals, Inc. today announced that Orphan Australia Pty Ltd, an Australian owned pharmaceutical company dedicated to providing novel, highly specialized pharmaceuticals, has been granted registration approval by the Therapeutic Goods Administration for DepoDur® in Australia. DepoDur, which was developed by and licensed from Pacira Pharmaceutical, Inc. and utilizes Pacira’s DepoFoam® technology, is a novel, single dose modified–release formulation of morphine.
The approved indication in Australia is “for the relief of post-operative pain, following major orthopedic, abdominal or pelvic surgery via the lumbar epidural route, at a maximum recommended dose of 10mg. Appropriate monitoring must be maintained for 48 hours.”
A single injection of DepoDur into the lumbar epidural space may provide pain relief for up to 48 hours, following major orthopaedic, abdominal or pelvic surgery without the restrictions and potential complications associated with an indwelling epidural catheter.
“We are pleased to add an innovative product like DepoDur to our growing hospital product portfolio” said John Michailidis, the Chief Executive Officer of Orphan Australia. “It fits well with our philosophy of providing specialists with novel, highly specialized 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”.
DepoDur will be available in Australia from February 2008.