Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

ADF Wars: Opana Unsafe For Any Need

WeeZuhl read your post a little while back about the crush resistant hard turtle shell ADT turning to a gel and possibly being a contributor to blood clots.

Could you point me to your posting of this again?

JJ, I'll see your clotting disorder and raise you a Hepatitis C Outbreak. The post you are referring to points to a Milwaukee Journal Sentinel report about a sharp increase in clotting disorders associated with IV abuse of the ADF version of Opana introduced in 2012.


http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113562295

Those determined to abuse the drug couldn't foil the anti-snorting mechanism, but they found a way to melt it down and inject it, with the help of larger-gauge needles that could channel the thicker substance into veins.

A MedPage Today/Milwaukee Journal Sentinel analysis of data from the FDA's adverse events reporting system found that blood-clotting disorders tied to Opana have grown in the wake of the new abuse-deterrent formulation.

In the four years before reformulation, there were two cases of blood-clotting disorders with Opana as the primary suspect. But in 2012, there were 53 cases — accounting for some 5% of all adverse event reports where Opana was the primary suspect.

And we had previously discussed how IV abuse of Opana was implicated in an HIV outbreak in rural Indiana. This post points to a CNN article.



http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113095685

Another reason this infection has spread so rapidly is the nature of the drug itself. Opana, as the prescription opioid is known, needs to be injected more than once a day. Duwve said residents have reported injecting it four to 10 times a day to stay under its influence. When people start to feel the drug wear off after about four hours, they begin to feel sick and go into withdrawal. Often they'll turn to an injecting partner in the same house who will share their needle and their drug to give the person relief from these symptoms.

Now there is an article in Bloomberg which ties Opana to an increase Hepatitis C infections. Again, it has been linked specifically to hardshell ADF mechanism.


http://www.bloomberg.com/news/articles/2015-05-07/abuse-of-pain-pills-fuels-virus-s-spread-confounding-regulators

Since hepatitis C can live for two to three weeks on surfaces, people can pass the virus through other drug paraphernalia, not just needles, Zibbell said.

The abuse-deterrent features of Opana may even help pass the virus. When they prepare the drug, addicts may use more cotton balls as filters, water to cook or injections to get high -- all adding up to more opportunities for exposure.

Make no mistake about it, in the very near future you will see Endo voluntarily withdraw Opana or they will see it withdrawn by the FDA. It is functionally useless as an ADF while at the same time it is specifically the ADF mechanism which is causing major morbidity.


From the Bloomberg article:

Abuse-deterrent technologies add to the cost of drugs, and some work better than others. For now, the pills remain on the market, and infections caused by their abuse continue.

“We need more research into abuse-deterrent forms of drugs,” Jerome Adams, Indiana’s state health commissioner, said on a call with reporters. “Just because a drug comes in an abuse-deterrent form, it doesn’t automatically make it safe.”