Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Doc, pure speculation on my part...

WHAT time release component?? Plain as day that it is immediate release. who says so?? the company LOL LOL

A Multi-center, Randomized, Multiple-dose, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Abuse-deterrent Immediate-release Capsules Oxycodone Hydrochloride, Naltrexone Hydrochloride 1.5 mg or Oxycodone Hydrochloride, Naltrexone Hydrochloride 3.0 mg for the Treatment of Adults With Moderate to Severe Pain Following Bunionectomy Surgery

Just an educated guess... What's your opinion on "abuse deterrent immediate-release" phrasing above?


http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112292755

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.