Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Study is poorly designed to test only naltrexone.

IMO then, this FDA pain efficacy trial is then trialing the Naltrexone sequestering polymer over 48 hrs with eight 15 mg IR Oxycodone while still maintaining pain relief. In 48 Hrs the Naltrexone beads will be throughout the patient's body from stomach, blood and Intestinal tract and exposure range thru hi acid, hi alkaline fluids as well as metabolizing enzymes environment.

The main argument against this is that the control arm is "placebo." If the FDA was really testing the naltrexone then the control arm would not be placebo but rather would be oxycodone 15 mg without naltrexone. As such, this study is poorly designed to test naltrexone since there is no control arm.