Collegium announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to update the labeling for Xtampza ER (oxycodone extended-release). Xtampza ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The labeling now includes comparative oral pharmacokinetic data from 2 studies evaluating the effect of crushing Xtampza ER vs. the abuse-deterrent version of OxyContin (oxycodone HCl extended-release) and a control (oxycodone immediate-release). Also, data from an oral human abuse potential study comparing intact vs. manipulated Xtampza ER to oxycodone immediate-release were also included in the updated label. In this study, there were statistically lower mean Drug Liking and Take Drug Again Visual Analogue Scale scores with oral administration of chewed and intact Xtampza ER in the fasted state vs. administration of crushed oxycodone immediate-release; both scores were similar for Xtampza ER administered in the intact or chewed states.
An oral abuse deterrent claim has also been added to the labeling, indicating that the product possesses physicochemical properties that are expected to reduce abuse via the oral route.
“With the addition of comparative pharmacokinetic data with OxyContin and an oral abuse deterrent claim, Xtampza ER is the only single agent oxycodone with oral, intranasal and intravenous abuse deterrent labelling,” said Michael Heffernan, CEO of Collegium.
Xtampza ER, a Schedule II controlled substance, is available as 9mg, 13.5mg, 18mg, 27mg, and 36mg strength extended-release capsules in 100-count bottles.
For more information call (855) 331-5615 or visit XtampzaER.com.