Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Lasers, why would IR-ADT defeat the purpose of ADT? Drug abusers crush and snort oxy-IR and Percocet exactly as they do OxyContin, probably more so because the oxyIR and Percocet are so much more ubiquitously prescribed than ER formulation and they do not come with a turtle shell abuse blocker. The naltrexone bead will prevent this kind of crushing abuse in IR opioids just the same as it prevents crush-type abuse with ER opioids. Naltrexone bead will not prevent oral abuse with either ER or IR opioids, unless it is crushed first (i.e. "parachuting"). However, one could make an argument that adding a time-release component to oxy-IR such that it releases over 6-8 hours instead of 3-4 hours is, in itself, a minor deterrent to oral abuse.

The abuser might prefer the ER opioid because bigger dose gives bigger high with less filler material to snort/inject, but as the chart below shows, ER opioids are but a drop in the giant bucket of IR opioids.

http://www.chronicpainperspectives.com/articles/feature-article/article/risk-evaluation-and-mitigation-strategies-rems-red-tape-or-a-remedy-for-opioid-abuse/8dd36b8e70b1db8988b98310efa863c9.html





According to my references, OxyIR comes as 5mg, 10mg, 15mg, and even 30mg, so this could very well be plain old OxyIR. The reason I believe this is an intermediate time-release opioid and not an immediate-release (oxyIR) is because 15mg would be far too sedating in an opioid-naive patient (especially 3 doses in 12 hours), and the study's exclusion criteria clearly excludes anyone with any concurrent opioid use (#21) or oxycodone exposure within 30 days (#26).

In summary, in my opinion, Elite is testing an intermediate-release ADT-oxycodone product which would be dosed at 6-8 hour interval instead of 4-6 hours for oxyIR or 12 hours for OxyContin. As far as I can tell, there is no direct comparator to this product, which may be why the efficacy trial is needed in the first place.

Why do I think this is a big deal? See the chart above for the number of IR prescriptions vs. ER prescriptions. What the intermediate-release oxy will do is the straddle the line between both. Okay to use on an as needed (PRN) basis for acute/temporary problem, but also okay to use on a scheduled basis for longer term pain issues. Also, okay to use scheduled every 8 hours with an extra as needed dose for breakthrough pain. As I said earlier, a GAME CHANGER. A new, novel drug that can be used as both an IR and ER.

Oh, Nasrat... my, my, my...



BTW and FYI, "parachuting" as mentioned above is a method of oral drug abuse in which the tablet(s) are crushed, wrapped in tissue, and swallowed. This allows for rapid G.I. absorption and therefore approximates the rush of snorting.