I’m just looking for some clarification on Elite and its ART products. I’m new to elite and to this forum. But I was doing a little DD and I came across some articles and information that I would like for this forum to help me clarify. Doing a simple Google search, I was found and article that mentioned a product that used a similar technique as elite called Embeda. Does elite add another process to the mix? I hope this isn't a long read.
“Another entry into the abuse-proof market, an agonist-antagonist, is the morphine sulfate-naltrexone combo marketed as Embeda. The antagonist naltrexone -- which blocks opioid receptors -- remains latent if the drug is taken as prescribed, but can reduce the effects of the morphine, or even lead to withdrawal, if crushed. But Embeda was recently pulled from the market because of stability problems and will likely remain unavailable for many months, according to reports.”
And another article mentions this about Embeda; “Nor did Alpharma's registration studies establish whether naltrexone's reduction of morphine effects following chewing or crushing was clinically significant. The product's label cautions that there is no evidence that Embeda is less likely to be abused than other extended-release morphine drugs.
In fact, it carries this warning: "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."
You can also read on iHub, Elite Pharma forum, post titled: "WHY MIK001 = A BETTER EMBEDA", posted by user "Couch". Note, this is a user opinion, not necessarily fact, but can aid in your own DD and what to research further. GLTAL's...
"Now you add in that Pfizer sues Watson over Embeda patent infringement and wins. That Actavis previously manufactured Embeda and then Watson purchases Actavis. Now Actavis has had to divest their right to manufacture Embeda and then Mikah hires Elite to develop Mik001. This leads Mik001 to be a Better Embeda.......as you can rule out Opana and Oxecta as Actavis already has generic rights to these drugs. You can rule out Oxycontin as Epic is developing this Anda. I think you rule out Exalgo because for Elite to develop this you wouldn't use a 5052b but an Anda.
So for the 5052b NDA that Elite is developing for Mikah/Actavis.....you have to choose either Embeda or Suboxone and Suboxone uses Naloxone not Naltrexone. There you have it MIK001 = A Better Embeda"