It was not too long ago the drug maker, Mallinckrodt, received their patent for the drug. In addition the extended use technology was used from Depomed for the new drug and this will generate a $ 5 to 10 million dollar license for that company as well.
We are aware of the focus on pain killer drug abuse and this new formulation is stated to help address some of it and is the only extended use oxycodone with acetaminophen on the market with this approval.
This is a controlled substance opioid drug of course and there’s a lot of education material and warning that go along with it, even with the Acetaminophen content warning of liver damage as well as the standard warnings for addiction.
About XARTEMIS™ XR
“XARTEMIS XR is an extended-release oral formulation of oxycodone hydrochloride and acetaminophen with immediate-release and extended-release components. It is not interchangeable with other oxycodone/acetaminophen products because of differing pharmacokinetic profiles that affect the frequency of administration. XARTEMIS XR is a schedule II controlled substance. “
DUBLIN--(BUSINESS WIRE)--Mallinckrodt plc (NYSE: MNK) today announced that the U.S. Food and Drug Administration (FDA) has approved XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated or would otherwise be inadequate. XARTEMIS XR is the first and only extended-release oral combination of two clinically proven pain medications -- oxycodone and acetaminophen.
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. The product’s release profile combines Mallinckrodt’s newly patented technology, including design, formulation, pharmacokinetic and release characteristics, and Depomed’s advanced Acuform® drug delivery technology.
The approval is based, in part, on the pivotal Phase 3 efficacy study conducted in an acute post-surgical pain model. XARTEMIS XR met the study’s primary endpoint and showed statistically significant improvement in pain scores compared to placebo from baseline over 48 hours.
This drug is the first and only extended-release oral combination of two pain medications oxycodone hydrochloride and acetaminophen. and this approval is based, in part, on the major Phase III efficacy trial conducted in an acute post-surgical pain model.ReplyDelete