US regulators have issued a green light for Mallinckrodt's new abuse resistant, opioid-based pain drug Xartemis.
The drug (previously MNK-795), is a controlled-release oral formulation of oxycodone and acetaminophen, formulated with Depomed's Acuform drug delivery technology to cut the risk of abuse by delivering active substances to the upper gastrointestinal tract in a controlled manner.
The US Food and Drug Administration (FDA) has now cleared its use for the management of acute pain in patients unable to take alternatives (e.g. non-opioid analgesics) because they are ineffective, not tolerated or would otherwise be inadequate.
Approval came on the back of data from a pivotal Phase III efficacy study conducted in an acute post-surgical pain model, which showed that Xartemis improved pain scores compared to placebo from baseline over 48 hours.
The addition of another option to the analgesics arsenal is good news for patients given that, despite the number of available painkillers, unresolved pain and lack treatment options that offer fast-acting and long-lasting relief remains a reality for a significant number.