FDA: Generic Opioids Must be 'No Less' Abuse-Deterrent Than Brand-Name Versions

http://www.raps.org/Regulatory-Focus/News/2016/03/24/24629/FDA-Generic-Opioids-Must-be-No-Less-Abuse-Deterrent-Than-Brand-Name-Versions/

Does this mean there won't be anymore abusable extended-release RX opiates in the USA in a few months?

Oxycodone, oxymorphone, hydrocodone, and morphine already have abuse-deterrent properties.


Comments


[1 Points] None:

I had no idea the concept of abuse-deterrent technology existed until now. I was at a gov't panel in Massachusetts several months ago where they talked about the initiatives they're taking to combat their opioid problem (it's kinda funny how when the issue spreads to the suburbs people start giving a shit). I'm surprised they didn't mention this. Would it be wrong to assume the poorer population probably tends to use generic medications more?

Thanks for the link, by the way, interesting read!


[1 Points] Lightshow33:

What do you consider to be an abusable ER opiate? I don't see how this is going to effect much. Oxycontin didn't have a generic. Opana ER doesn't have a generic. Hydrocodone ER didn't have a generic. MS contin does have generics but they're less abusable than the brand name, or at least they were in the past. I've never seen Hydromorphone ER so I'm not sure how abusable they are in comparison to their brand name counter part. The only problem I can see arising is a jump in price on Morphine ER.


[1 Points] Hi_Im_New_Here___:

Purdue and Endo lost billions in terms of class action awards and lost revenue due to spreading FUD on Oxycontin and Opana ER. As their patents approach expiration, the FDA now decides to be the good samaritan, while ensuring that generic manufacturers have to spend a shitload of time and money to reformulate pills? All while doctors (if they even still prescribe) will start to mandate no generic substitution? "Could it be the man behind the man behind the man that's on the throne?"

The drug that will be interesting in this is Zohydro. It is extend release hydrocodone and it was somewhat controversial because the pill was so easily converted into instant release powder. The patent still has a lot of life left. The manufacturer made claims that they were working on a way to reformulate the pill. They didn't seem to be in a big hurry though, as the formulation was protested every step of the way through development - years before being approved. Anyway, this could provide an exception. Good luck getting a script though.


[0 Points] None:

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