Replies to post #269817 on Elite Pharmaceuticals Inc (ELTP)

[jbdiver]

Well thought out and nicely stated. That is pretty much what I got out of that this morning "Sequestox is not dead"
I understand why they used the tmax benchmark that they did. But im sure they will broaden the acceptable dispersion numbers. It was kind of comparing apples and oranges. Im hoping once they get better insight we will move right along. imo Im not a dr or scientist. But i do believe eventually the powers that be will be overcome by political and social outcry.

[lasers]

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

[senderos]

Great perspective on what these poster presentations mean, or might mean.