The US Food and Drug Administration (FDA) has approved Irish pharmaceutical firm Mallinckrodt‘s XARTEMIS XR extended-release tablets (CII), previously known as MNK-795, for treatment of acute pain.
XARTEMIS XR is the first and only extended-release oral combination of two pain medications oxycodone hydrochloride and acetaminophen approved for acute pain.
It is intended for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options are ineffective, not tolerated or would otherwise be inadequate.
The FDA approval is based, in part, on the major Phase III efficacy study carried out in an acute post-surgical pain model.
In the Phase III efficacy trial, XARTEMIS XR met the primary endpoint and showed significant improvement in pain scores compared to placebo from baseline over 48 hours.
The company said that XARTEMIS XR has both immediate- and extended-release components formulated to provide onset of pain relief in less than one hour and to allow twice daily dosing.
XARTEMIS XR’s release profile combines the company’s newly patented technology, including design, formulation, pharmacokinetic and release characteristics, and Depomed’s advanced Acuform drug delivery technology.
The approval triggers a $10m payment to Depomed under a licensing agreement signed by the two companies.
Depomed will recognise the entire milestone payment in the first quarter of 2014 and also receive high single digit royalties on net sales of the product.
As well as the efficacy trial, the company had also conducted extensive lab testing and a human abuse liability trial with XARTEMIS XR.
Depomed president and CEO Jim Schoeneck said Acuform technology has contributed to this important new therapy option for patients and their physicians.
"We expect to receive significant recurring royalty revenue from Mallinckrodt’s commercialisation of XARTEMIS XR," Schoeneck said.
"Mallinckrodt has also licensed the Acuform delivery technology under equivalent royalty and milestone terms for its MNK-155 product candidate, which has been studied for moderate to severe acute pain."
In addition, Mallinckrodt intends to file a new drug application (NDA) for MNK-155 in the second half of its 2014 fiscal year.
According to the company, FDA acceptance of MNK-155 NDA would trigger a $5m milestone payment to Depomed and approval by the FDA would trigger an further $10m milestone payment.
Mallinckrodt president and chief executive officer Mark Trudeau said: "Mallinckrodt remains committed to continuing its work to develop innovative formulations for our product lines to help ensure access to appropriate pain treatment for the millions of patients suffering from acute pain, and we will continue to work closely with the FDA as we engage in further development programmes for XARTEMIS XR and other products utilizing this technology platform."