CSL subsidiary Seqirus has announced the launch of its first product under its recently adopted name.
Seqirus, formerly known as bioCSL, has launched CALDOLOR in Australia, a new intravenous formulation of ibuprofen, registered for the management of post-operative pain and reduction of fever in adults.
CALDOLOR is designed primarily for patients in the hospital setting undergoing surgery and who require ongoing analgesia in an intravenous form. Ibuprofen in its oral formulation has been used extensively by millions of people in Australia since it was first registered in 1969.
According to the company, in clinical trials of orthopaedic and gynaecological surgery, CALDOLOR 800mg was identified as the optimal dose to manage post-operative pain and reduce morphine use by up to 31 per cent compared with placebo.
It said CALDOLOR 800mg can be started during surgery with the flexibility to continue on the same molecule post-operatively, or transition to an oral formulation. In these studies, patients administered CALDOLOR 800mg did not show an increase in the incidence of renal dysfunction, gastrointestinal bleeding or requirement for transfusion compared to placebo.
"The introduction of IV ibuprofen (CALDOLOR) in my experience has allowed Anaesthetists to achieve improved pain control compared to on demand opioids alone, with less reliance on opioid analgesic medication, thereby improving patient satisfaction," said Dr Daniel Sajewski, Anesthesiologist and Director of Pain Management at St Francis Hospital in New York, and a keynote speaker at the Australian Society of Anaesthetists Congress held earlier this year.
Dr Gavin Pattullo, Senior Staff Anaesthetist and Director of Acute Pain Service, Royal North Shore Hospital, welcomed the launch of CALDOLOR in Australia.
“Pain with movement in our nil-by-mouth patients has for a long time been undertreated. The availability of CALDOLOR now provides another clinically useful option,” he said.
CALDOLOR is distributed in Australia by Seqirus under license from Cumberland Pharmaceuticals who developed and registered the product in the US.
"We are delighted to work with our partner Seqirus to bring CALDOLOR into Australia, offering a new level of patient care as ibuprofen advances to IV," said A.J. Kazimi, Cumberland’s CEO.
"CALDOLOR has been widely available in the United States since 2009, with over one million doses sold since its launch.”
“We recognise that improving access to additional pharmacological options for post-operative pain is very important to Australian healthcare professionals and patients,” said Seqirus’ Vice President of Asia Pacific Commercial Operations, Dr Lorna Meldrum. “CALDOLOR is an important addition to Seqirus’ growing product range and further strengthens our pain portfolio of in-licensed medicines in Australia,” she said.
