FDA: Reformulated OxyContin Might Have 'Advantage'

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smackem

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http://online.wsj.com/article/BT-CO-20090922-711209.html

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)--The Food and Drug Administration said Tuesday a reformulated version of the powerful painkiller OxyContin designed to make the product harder to misuse or abuse "may provide an advantage" over the current product.

However, the agency said the tamper resistant properties of the new version OxyContin "are limited" in documents posted to its Web site Tuesday in preparation for an FDA advisory meeting ...


http://www.injuryboard.com/national...ers-less-chance-of-abuse.aspx?googleid=271292

OxyContin




The maker of the painkiller, OxyContin has applied to the Food and Drug Administration to reformulate the pill to reduce the chances of misuse or abuse.

Purdue Pharma LP wants the drug to be tamper-resistant so it’s harder to crush and dissolve in water. The active drug would be released as a gel making it harder to inject, according the FDA staff reporting on the agency’s Web site.

Drug abusers typically dissolve or crush the drug and put it in water to inject it for a heroin-like effect.

Two years ago, the company had to pay $635 million to settle federal charges that it underplayed the drug’s potential for abuse. Addiction rates are reported to be between 1 and 13 percent.

Purdue is in a race with King Pharmaceuticals Inc, which is reformulating oxycodone, the active drug in OxyContin. Outside advisors will meet on the application Thursday.

Last year the FDA refused a request to reformulate OxyContin, saying there was not enough information on the new version. This time around Purdue will leave out information about the tamper-resistant qualities in the product’s label, reports the Wall Street Journal.

OxyContin was approved by the FDA in 1995 to treat chronic pain. Radio host, Rush Limbaugh admitted an addiction to the drug in 2003, and sought treatment, narrowly averting felony charges for doctor shopping.

If approved, Purdue, of Stamford, Conn. will replace existing supplies with the new OxyContin-TR formula.

A report issued last year, Monitoring the Future: National Results on Adolescent Drug Use, finds that marijuana and alcohol use has declined while the abuse of painkillers such as Vicodin and Oxycontin has increased among teens.

Much of the drug use among the young is seen in white middle-class families. #



Read more: http://www.injuryboard.com/national...e-of-abuse.aspx?googleid=271292#ixzz0S8vJbqbL
 
so basically it sounds like the brand name OC are just gonna be similar to the old teva generics?

anyone got any ideas/guesses as to when these might get seen?
 
yea we all know this, but alot of people also prefer to abuse their oxy's.

i have never plugged anything before but i wonder if the gelling mechanism would effect absorbtion if one attempted to plug it? might be just enough of a reason to actually give plugging a try, that is ofcourse if i am no longer able to snort them ;)
 
Ason Unique said:
I don't see why they are just making it harder, this will just damage the people who will do it anyway more. And somebody is gonna find a way to abuse it anyways.
Click to expand...

It's very obvious why they are doing it: they get a patent extension on a drug that is off patent otherwise. Money in the bank, and the drug warriors are happy.
 
I remember the generics I got would gel up in your nose and and feel like they got you half as high. And when you crushed them and no matter how hard I smashed on those fuckers there were still chunks left which I think might affect absorbsion orally. So if it ends up like that use one of those hope clamps to grind it up to a fine powder
 
it is a bit baffling that the generic manufacturers were able to make things more tamper proof already, but Purdue could not (or would not). it is suspicious to say the least.
 
Don't worry folks, here is the abusers' roadmap the FDA warned Purdue about not making available, before the drug is even approved. In so doing, you'll even see the laboratory-verified %oxycodone returned for various simple, medium, and complex solvents with and without milling for both the original OC and tamper resistant (OTR) OP formulations.

FDA Advisory Committee on OTR, where Purdue pitches the formulation and all its intricacies for us to see at http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4356s1-05-Purdue.pdf and http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4356t1-index.pdf. Utterly fascinating read on the current perceptions in agency and sponsor of abuse (ah, were they only to just peruse this site). Here is a menu of the first day of the AC (http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4356s1-00-index.htm).

Want to know what mills they were using (simple=B&D Handy Chopper; complex=Fitzmill)? Solvents (simple series=H2O, EtOH, Vinegar, Cooking Oil, Baking Soda)? Insert the patent application's Table 27.5 data into the Simple Extraction Table on page 50 of the PPTs when Dr. Mannion is speaking. The application data is at http://appft.uspto.gov/netacgi/nph-...forms"&RS=TTL/"tamper+resistant+dosage+forms".

To spare you some of the hunt, in the original formulation, considering the toxicity and hassle of the medium and complex solvents, water and alcohol work best. But let's be honest, with the high bioavailability and ease of crushing, you might as well just crush and parachute. In the new formulation, though, better break out the HCl...

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Later.
 
Seems like all this will achieve is fucking the veins of IV drug users even worse and making the snorters spend extra time crushing up their pills. If there is oxycodone in these pills you can bet your ass they will still be abused.
 
This is just gonna fuck people's veins up even more....wonder if this will cause the prices to drop a little, though?
 
The OROS (R) Push/Pull system has been defeated, TimeRX has been defeated, countless attempts to prevent abuse have been defeated in the past.

There is no reason why this won't be defeated. TEVA's generics were defeated.

As already mentioned, it's all about patent extension.
 
Push/pull system was stupid easy to defeat. How was timerx defeated? And how was teva generic defeated?
 
I think the tevas where defeated using a microwave and water if im not thinking of something else. Its all for not heroin is on the comeback and usually a better option financialy anyway.
 
Does anyone have an update on this? I can't believe this started 5 years ago and still hasn't been released. Does anyone know an average or estimate on how much a physician gets paid by purdue pharma for prescribing oxycontin? It'd be interesting to see how much crooked doctor's actually sell their souls for haha.
 
Darkflame, i dont know if you are jokin or wat....but doctors dont "get paid by purdue for prescribing oxy." Sure drug company reps do all kinds of shit. they stay wineing and dineing the doctors and all that shit, but to say that each doctor who writes scripts for oxy actually gets paid cash per script aint how it works. Its corrupt and shady all right, and in some cases im sure there is back room deals goin down, but in general, doctors dont actually get cut checks from purdue for each script they write. I think you mighta heard people discussin this and got confused about how it actually works, or assumed that was the deal but it aint.
 
^^ i dont know about the corruption, but an old friend's mom was a drug rep and my GOD she had the coolest fucking ink pens i've ever seen....some of them looked like they could turn into a lightsaber if you click the button on top or said the secret password. man.
 
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