In response to Gudin et al. — Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties

Abstract

• "“It is likely that the ability to retain ER features following manipulation will make it less attractive to abusers compared to existing ADFs. . ."” This statement implies that these PK results are supported by comparative pharmacodynamic (drug liking effects) or human abuse potential study data, when such is not the case. • PK profiles of Xtampza ER and OxyContin were examined when ingested with food, "“as this is a common form of administration in the intended patient population.”" This statement is misleading as it suggests Xtampza can be dosed with or without regard to food, when such is not the case. Xtampza ER can only be taken with carefully modulated complete food intake. Failure to follow this stringent procedure, either by physician or patient, will result in variability in the extent of oxycodone absorption and ultimately impact the safety and efficacy of Xtampza ER. • "“Although results of this study showed some minor differences in the PK profile between intact Oxycodone DETERx and intact OxyContin, the two products were bioequivalent on Cmax, AUClast, and AUCinf.”" Authors fail to clarify that Xtampza ER is not bioequivalent to OxyContin in fasting condition. Stated as such, this statement invites the potential for serious dosing errors with OxyContin.