PMID- 22357166
OWN - NLM
STAT- MEDLINE
DCOM- 20141106
LR  - 20151119
IS  - 1536-3686 (Electronic)
IS  - 1075-2765 (Linking)
VI  - 21
IP  - 2
DP  - 2014 Mar-Apr
TI  - A single-dose, 3-way crossover pharmacokinetic comparison between 
      immediate-release oxycodone hydrochloride with aversion technology (IRO-A, 
      Oxecta), IRO-a with Niacin, and Oxycodone Hydrochloride (Roxicodone) in healthy 
      adults under fasting conditions.
PG  - 99-105
LID - 10.1097/MJT.0b013e3182456d9b [doi]
AB  - Snorting and intravenous use are common routes of administration for advanced 
      opioid abusers. A tablet form of immediate-release oxycodone (IRO) developed 
      using Aversion Technology combines immediate release (IR) oxycodone HCl with 
      inactive functional excipients that are intended to discourage tampering 
      associated with intranasal and intravenous abuse (IRO-A; Oxecta, Pfizer). The 
      purpose of this single-dose, open-label, randomized, 3-period, 3-treatment 
      crossover study was to evaluate the bioequivalence of IRO-A to the marketed 
      immediate-release oxycodone HCl (IRO; Roxicodone, Xanodyne Pharmaceuticals Inc., 
      Newport, KY). IRO-A was also compared with IRO-A with niacin, a product 
      previously developed containing the same functional excipients plus niacin as an 
      aversive agent to discourage oral overconsumption. Healthy adults (N = 40) aged 
      18-55 years received single 15-mg doses of IRO-A, IRO-A with niacin (60 mg), or 
      IRO after fasting overnight. Naltrexone was administered to diminish opioid 
      effects. Doses were separated by a >/=7-day washout. Plasma samples taken at 
      designated time points were analyzed using liquid chromatography with tandem mass 
      spectrometry. Geometric mean ratios for ln-transformed parameters for IRO-A and 
      IRO were 92%, 104%, and 104% for Cmax, AUClast (AUC is area under the 
      concentration-time curve), and AUCinf; 90% confidence intervals were within the 
      accepted 80%-125% range. IRO-A was also bioequivalent to IRO-A with niacin. 
      Adverse events were mild to moderate in intensity and typical of opioid therapy 
      (nausea, headache, vomiting). Flushing only occurred when the subjects received 
      the IRO-A with niacin treatment (9/37 subjects). The results demonstrated that 
      IRO-A is bioequivalent to IRO and IRO-A with niacin. With features designed to 
      discourage tampering associated with common forms of abuse, IRO-A may provide an 
      alternative to conventional immediate-release oxycodone formulations.
FAU - Leibowitz, Mark T
AU  - Leibowitz MT
AD  - 1Clinical Research Services, Worldwide Clinical Trials Drug Development 
      Solutions, San Antonio, TX; and 2Technical Affairs, Acura Pharmaceuticals Inc, 
      Palatine, IL.
FAU - Zamora, Cynthia A
AU  - Zamora CA
FAU - Brzeczko, Albert W
AU  - Brzeczko AW
FAU - Stark, Jeffrey G
AU  - Stark JG
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Ther
JT  - American journal of therapeutics
JID - 9441347
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Excipients)
RN  - 0 (Tablets)
RN  - 2679MF687A (Niacin)
RN  - 5S6W795CQM (Naltrexone)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Analgesics, Opioid/administration & dosage/adverse effects/*pharmacokinetics
MH  - Area Under Curve
MH  - Cross-Over Studies
MH  - Excipients/*chemistry
MH  - Fasting
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Naltrexone/administration & dosage/pharmacology
MH  - Niacin/*administration & dosage/adverse effects/chemistry
MH  - Opioid-Related Disorders/prevention & control
MH  - Oxycodone/administration & dosage/adverse effects/*pharmacokinetics
MH  - Tablets
MH  - Therapeutic Equivalency
MH  - Young Adult
EDAT- 2012/02/24 06:00
MHDA- 2014/11/07 06:00
CRDT- 2012/02/24 06:00
PHST- 2012/02/24 06:00 [entrez]
PHST- 2012/02/24 06:00 [pubmed]
PHST- 2014/11/07 06:00 [medline]
AID - 10.1097/MJT.0b013e3182456d9b [doi]
PST - ppublish
SO  - Am J Ther. 2014 Mar-Apr;21(2):99-105. doi: 10.1097/MJT.0b013e3182456d9b.