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
نویسندگان
چکیده
• "“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.
منابع مشابه
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”
متن کامل
Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties.
OBJECTIVE Oxycodone DETERx® is an extended-release (ER), microsphere-in-capsule abuse-deterrent-formulation designed to retain its extended-release properties following tampering or misuse (e.g., chewing, crushing). This study assessed the safety and pharmacokinetics of orally administered intact and crushed Oxycodone DETERx® capsules compared with intact and crushed reformulated OxyContin® tab...
متن کاملOxycodone DETERx®: A Novel Abuse-Deterrent, Extended-Release Analgesic Option for the Treatment of Patients with Chronic Pain
BACKGROUND Extended-release (ER) opioid analgesics are commonly used to provide safe and effective pain relief to treat pain severe enough to require around-the-clock, long-term dosing. These ER opioid formulations usually contain more drug per dosage unit than immediate-release (IR) agents, and therefore bring with them challenges related to both opioid abuse and misuse, often through manipula...
متن کاملOral Human Abuse Potential of Oxycodone DETERx® (Xtampza® ER)
Oxycodone DETERx® (Collegium Pharmaceutical Inc, Canton, Massachusetts) is an extended-release, microsphere-in-capsule, abuse-deterrent formulation designed to retain its extended-release properties after tampering (eg, chewing/crushing). This randomized, double-blind, placebo-controlled, triple-dummy study evaluated the oral abuse potential of intact and chewed oxycodone DETERx capsules compar...
متن کاملThe effect of abuse-deterrent extended-release oxycodone leads to inappropriate conclusions with over estimation of safety of abuse-deterrent formulations.
Larochelle et al (1) published an original investigation on rates of opioid dispensing and overdose after the introduction of abuse-deterrent, extended-release oxycodone and the withdrawal of propoxyphene in the JAMA Internal Medicine. We believe that Larochelle et al may have misinterpreted the causes of opioid overdoses and the consequences of abuse-deterrent opioid formulations. These assump...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
دوره 18 شماره
صفحات -
تاریخ انتشار 2017