Response to Crudele et al. Commentary on Gudin et al. “Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties”

Abstract

Dear Editor, We appreciate Crudele and colleagues taking the time to read our publication “Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties” [1], in which the pharmacokinetic (PK) profiles of manipulated Xtampza extended release (ER) were compared with manipulated reformulated OxyContin. We are grateful to the editors for a chance to respond to their comments. Crudele states that the paper “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.” The study in reference (Gudin et al. 2015) [1] did not collect comparative pharmacodynamic data as the differences of the PK results of the manipulated treatment groups were quite compelling and stand on their own: Crushed Xtampza ER (oxycodone) had a PK profile that was bioequivalent to Xtampza ER taken intact (Figure 1A) [1]. This was in contrast to the crushed OxyContin (oxycodone HCl) profile, which was significantly different than OxyContin taken intact and bioequivalent to crushed immediate-release oxycodone tablets (Figure 1B) [1]. The data presented in the referenced study have been recently duplicated in a second study [2] and are …