Replies to post #149429 on Elite Pharmaceuticals Inc (ELTP)

[lasers]

Perhaps the FDA has said to prove that $ELTP's drug is equivalent to the "Pain Efficacy" as the drug that is currently under FDA trial which could be Pfizer's ALO-02.

[lasers]

WeeZuhl On an equivalent analgesic 15 mg Oxycodone and 20 mg Morphine are likely to be the same. Embeda has a 20mg Morphine combined with 0.8 mg Naltrexone

Each 20 mg/0.8 mg extended-release capsule contains 20 mg of morphine sulfate and 0.8 mg of naltrexone hydrochloride in a two-toned yellow opaque capsule with "EMBEDA" printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has "20" reverse-printed in a grey circle.

Just possible that the FDA has requested $ELTP to use 15mg Oxycodone combined with either 1.5 mg or 3.0 mg Naltrexone to prove that $ELTP ADT delivery systems for both agonist and antagonist are equivalent to the Comparator that the FDA has chosen.

Very interesting that the FDA wants $ELTP to use immediate release delivery.

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

[dr_lowenstein]

game changer??? an IR form of Oxy for "bunionectomey" hardly LOL LOL

[no2koolaid]

While this is the good old USA and litigation is a form of caring, one can never tell (after all, people sue for putting hot coffee in their own laps and arguing they never thought it would burn them). Nonetheless, it would seem this transcends issues with patent infringement. As I am certain the hale and hearty legal minds indicated.