Embeda, a morphine/naltrexone combination delivered by capsule, was approved by FDA for use as a Schedule II drug, with the label: Embeda can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Embeda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. The key point is that there was no data filed with the registration suggesting that there was evidence that Embeda is less likely to be abused than other extended-release morphine drugs. In addition, in a clinical trial, 11% of patients have naltrexone showing up in their blood stream. Net, Embeda is viewed as a marginal improvement over morphine alone.
So we have Embeda we have a lot of emphasis by the vendors, manufacturers, drug companies, pharmaceutical agencies to try to develop substances which have deterrents against abuse. That doesn’t really solve the problem because for every system there is somebody who has the wherewithal, the knowledge, the background, the training, the experience to kind of thwart the efforts at limiting the abuse potential of every agent that has ever been developed. However, you need to be able to produce the drug without stability issues!
It has been since March 2011 and Pfizer obviously has not been able to correct the stability issues. Pfizer said it would have this fixed in a matter of months.
How this relates to Elite: Well, if they can prove that they do not have stability issues with their version of Embeda, things get very interesting. Furthermore, Elite's ART is the first I have seen that actually can mitigate those aforementioned folks with the wherewithal, knowledge and background to thwart the abuse resistant properties of the drug. This will be proved in the upcoming human abuse liability studies.
