Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Really???? Got any evidence to support that old nonsense about embeda? Sheeeeze

Of course I do. Do you think I just make this shit up? Sheeeeeze.

Embeda has stability issues because the naltrexone is within the core and very difficult to fully sequester. The designers were forced to limit the amount of naltrexone in each tablet because of the leakage, which will cause withdrawal symptoms in legitimate users. More naltrexone means more symptoms in legit users. Less naltrexone means more potential for abuse.

https://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4395b2-02-ALPHARMA.pdf

Naltrexone HCl 4.8 mg co-administration resulted in ≥30%
reduction in morphine-induced euphoria for >50% of subjects who completed the study, assessed
by VAS-Drug Liking. This degree of reduction in morphine drug liking mitigated by naltrexone
HCl would be expected to reduce morphine abuse potential.

In the above graph, the yellow line is the dose of naltrexone used in Embeda 120mg. As you can see, it is middling and clearly not the dose with greatest euphoria-blocking effect. Both C and D have better antagonist effect (approaching placebo); however, these higher doses were not used. Instead, the designers used a lower dose of naltrexone which they knew would only block 30% of euphoria effect in 50% of patients. They did this as a compromise. The higher doses of naltrexone would work better as an abuse deterrent, but they were not chosen for commercial use due to multiple reasons, especially unintended naltrexone leakage causing adverse effects in legitimate users.