WeeZuhl thxs. An excellent post.
(442) Pharmacodynamic data assessing the abuse potential of a
novel abuse deterrent oxycodone formulation (ELI-200)
compared to oxycodone immediate release, oral intact
ELI-200, and placebo in healthy, non-dependent recreational
opioid users following intranasal administration
B Setnik, K Schoedel, C Bartlett, C Dick, N Hakim, and P Geoffroy; INC
Research, Toronto, Ontario, Canada
Prescription (Rx) opioid abuse continues to be of concern. Abuse
deterrent formulations have been developed to discourage the
abuse of drugs by intended and/or unintended routes of administration.
The primary objective of this study was to assess the intranasal
abuse potential of a novel immediate release (IR) oxycodone formulation
containing sequestered naltrexone. This study was a randomized,
double-blind, double-dummy, active-and placebo-controlled,
5-way crossover study in compliance with local and international
regulations. Healthy, male and female non-dependent recreational
opioid users (aged 18 – 55 years, inclusive) underwent a naloxone
challenge, drug discrimination, and treatment phase. Single, intranasal
(IN) doses included crushed ELI-200 (30 mg oxycodone/3 mg
naltrexone), 30 mg oxycodone HCl IR, placebo, fixed placebo, and
orally administered, intact ELI-200 (30 mg/3 mg). Pharmacodynamic,
safety and pharmacokinetics were evaluated for up to 36 hours postdose.
The primary endpoint was the peak effect (Emax) for Drug
Liking [0-100 point Visual Analog Scale]. Of 44 randomized subjects
(mean age 38.3 years, 72.7% male), 37 completed. All active treatments
showed significantly higher (P<0.001) median Emax for Drug
Liking relative to placebo [51.0]. Relative to IN oxycodone IR
[100.0], ELI-200 showed significant reductions (P<0.001) in median
Drug Liking [Emax] when administered crushed IN [56.0] and orally
intact [83.0]. Secondary positive or objective measures (High, Good
Effects, Overall Drug Liking, Take Drug Again [TDA] and pupil size)
showed significantly lower Emax for IN ELI-200 (P<0.001) and oral
ELI-200 (P<0.008, except TDA P=0.187 and pupil size P=0.879)
compared to IN oxycodone IR. ELI-200 IN was generally well tolerated
with significantly higher nasal irritation ratings (P<0.05) relative
to IN oxycodone IR. ELI-200 mg showed significant reductions
in Drug Liking and other measures related to abuse potential
when crushed and administered IN to non-dependent recreational
opioid users
