Xtampza® ER: engineered to deliver powerful pain relief and help mitigate the risks of abuse, misuse, and diversion
Studies required by FDA to demonstrate the potential to help deter abuse
There are 4 categories (3 premarket and 1 postmarket) of studies FDA accepts to demonstrate a product’s potential to deter abuse.1
Manipulation and Extraction studies
Lab‑based in vitro manipulation and extraction studies to evaluate the ease with which the potentially abuse‑deterrent properties of a formulation can be defeated or compromised
Pharmacokinetic (PK) studies to compare profiles of manipulated and intact product through one or more routes of administration to understand the in vivo properties of the formulation
Human abuse potential clinical studies, assessing the impact of potentially abuse-deterrent properties on Drug Liking and Take Drug Again measurements
Postmarket analysis assessing whether the marketing of a product with abuse-deterrent properties results in meaningful reductions in abuse, misuse, and related adverse clinical outcomes, such as addiction, overdose, and death
No product, including Xtampza ER, has Category 4 data sufficient to support a label claim that it reduces abuse, misuse, or deterrence in the real world
Manipulation and Extraction studies
Results from in vitro physical and chemical manipulation studies support that Xtampza ER is less susceptible to the effects of grinding, crushing, and extraction using a variety of tools and solvents relative to oxycodone IR tablets.
Xtampza ER resisted attempts to pass the melted capsule contents or microspheres suspended in water through a hypodermic needle.2
Only Xtampza ER maintained its extended‑release PK profile when crushed—OxyContin® did not
In a randomized, open‑label, active‑controlled, 5‑treatment crossover study, Gudin et al compared the PK of crushed oxycodone IR to Xtampza ER (crushed and intact) and reformulated OxyContin (crushed and intact) taken orally in 42 healthy subjects.3
The findings above do not indicate that Xtampza ER can entirely prevent abuse via oral and nasal administration. Abuse of Xtampza ER by injection and by the oral and nasal routes is still possible.
The impact of the oral PK studies on diversion, misuse, and abuse of Xtampza ER has yet to be determined. Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of Xtampza ER on the abuse liability of the drug.
How does this make you rethink your ER oxycodone of choice?
Clinical Abuse Potential studies
Oral abuse: Xtampza ER demonstrated a statistically significant reduction in oral abuse potential vs oxycodone immediate‑release (IR)
The oral abuse potential of Xtampza ER was evaluated in two studies. Below are results from a study with 52 nondependent recreational opioid users who received active and placebo treatment orally. Drug Liking and Take Drug Again were measured on a visual analog scale (VAS).2
- The oral administration of both chewed and intact Xtampza ER in the fasted state was associated with statistically lower mean Drug Liking and Take Drug Again scores compared with crushed oxycodone IR
- In addition, the Drug Liking and Take Drug Again scores were similar for Xtampza ER taken in the intact and chewed states
Abuse of Xtampza ER by injection and by the oral and nasal routes of administration is still possible.
Nasal abuse: Xtampza ER demonstrated a statistically significant reduction in nasal abuse potential vs oxycodone immediate-release (IR)
The nasal abuse potential of Xtampza ER was evaluated. Below are results from a study with 36 recreational opioid users with a history of intranasal drug abuse who received active and placebo via nasal administration. Drug Liking and Take Drug Again were measured on a VAS.2
- Intranasal administration of crushed Xtampza ER was associated with statistically lower mean Drug Liking and Take Drug Again scores compared with crushed oxycodone IR
These findings do not indicate that Xtampza ER can entirely prevent abuse via nasal administration. Abuse of Xtampza ER by injection and by the oral and nasal routes of administration is still possible.