New Formulation of Oxycontin– Will it make a difference?

Oxycontin was not my drug of choice so I don’t know the ins and outs of abusing the medication. But I suppose anything that makes the drug harder to abuse is a good thing. The other things that are being looked at for approval are combinations of agonist with antagonist in small doses– for example Embeda is morphine plus little beads of naltrexone, and orally-active form of naloxone. The naltrexone is only released if the pill is crushed, and there is not enough naltrexone to cause withdrawal, but only enough to reduce the ‘high’. I guess my thought is why limit to a small amount of naltrexone? The drug is not to be injected or snorted, so why not put enough naltrexone in it to make any tampering a very serious downer?
I thought I’d share the article below with you, so you can see how thrilled the FDA is with the new formulation.  Read on…
FDA Panel Recommends Approval of New Oxycodone Formulation
By Emily P. Walker
Published: September 24, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine.
GAITHERSBURG, Md. — An FDA advisory panel voted to recommend approval of a new formulation of oxycodone hydrochloride (OxyContin) that is more difficult to crush or dissolve, and which may deter drug abuse.
By a 14-4 margin, with one abstention, the panel recommended that the FDA approve Purdue Pharma’s application for a new, resin-coated formulation that it hopes will eventually replace the original version, which has been on the market since 1996.
The FDA does not have to follow the advice of its advisory committees, but it usually does.
The advisory panel’s endorsement was less-than-enthusiastic in this case, and members complained that there’s no proof the new version of the drug is any safer than regular oxycodone hydrochloride — one of the few drugs on the market that can be deadly in a single dose.
Purdue’s current pill is meant to be swallowed whole, but abusers can easily chew it or crush it and then snort it, smoke it, or dissolve it in liquid and inject it to achieve a heroin-like high.
Although there is no proof that the new formulation is safer, the panel agreed that making the pills harder to crush, chew, or dissolve into liquid may deter abusers. When the new version of the drug is dissolved into water, it produces a gel, which makes snorting the drug more difficult.
“Clearly the old [formulation] is worse than the new, although I think the difference is relatively small,” said panelist Randall Flick, MD, an anesthesiologist at the Mayo Clinic who voted to recommend approval of the drug.
“My feeling is that there would at least be some incremental improvement in the safety profile,” said panelist Stephanie Crawford, PhD, a pharmacist at the University of Illinois in Chicago.
Some 1.2 million people age 12 and older used OxyContin in 2006 for nonmedical purposes, according to the Department of Health and Human Service’s National Survey on Drug Use and Health.
Purdue originally sought FDA approval for low-dose versions of the new product in 2008, but the agency told the company to develop more clinical data and to apply the technology to all dosages of the drug.
Also, it took until 2008 for the company to convince the advisory panel in 2008 that the drug was any more difficult to tamper with than the original formulation, said panelist Ruth Day, PhD, director of the Medical Cognition Laboratory at Duke University.
This time around, the company convinced the panel that new tablet is harder to dissolve or crush and that the resin excipient might make it harder to take the drug in an unprescribed manner, said Day, who was also a member of last year’s panel.
In one lab test, Purdue researchers used 16 household tools to attempt to crush the tablet into small particles. All 16 tools handily crushed the original OxyContin tablets to a fine powder. Although four of the tools managed to break down the new tablet into shavings or particles, none could turn it into powder.
Even so, FDA staff reviewers concluded that the technology does not make a huge difference in OxyContin’s abuse potential.
Hardcore abusers are likely to devise new ways to break down the harder tablet or figure out which solvents will dissolve it fastest, within “day or weeks of the product’s release on the market,” Flick predicted.
The panelists who voted for approval said they were concerned that Purdue had not developed an adequate Risk Evaluation and Mitigation Strategy for the drug.
The new formulation will keep the name “OxyContin” and be used in seven available doses. Purdue said it will not market the reformulation as a “safer” version.
If it’s approved, Purdue will produce only the newer version and stop shipping the old one.
“Within six to eight weeks [of production] roughly 90% of drug in the supply chain will be the new product,” said Craig Landau, MD, Purdue’s chief medical officer.

New Discoveries After Suboxone, Continued

Coincidentally, just as I posted last night’s post about my excitement for capitalism’s new interest in addiction medication, a very interesting post appeared on Bluelight (a very interesting site about drug use and abuse) about the same general idea– but with a different perspective.  I am going to try to get the person who posted there to do a ‘guest post’ for us here, so that we can have a ‘point/counterpoint’ discussion about the topic.  I may be wrong, but I think the post I’m referring to takes issue with the money made by ‘big pharma’ as they produce these new medications.  I have probably made it clear that I don’t feel that way;  the companies that make our medications take huge risks when they choose to develop a medication, and there would be nobody taking risks if not for some reward at the end.  Besides, all of those profits don’t go to a guy wearing a suit, smoking a cigar– the image that politicians use to pit people against each other during campaigns–  the profits go to everyone with an IRA or pension fund, or anyone lucky enough to still have some mutual fund holdings after the past year or two!
I will copy a couple parts of the post below.  The people at Bluelight are generally quite sophisticated in their drug knowledge, although the opinions expressed there are more the ‘street’ perceptions and attitudes, rather than ‘medical’.  The original post can be found here.
Narcan: The Next Big Thing In Pain Management
They’re going too far.
…It all started with Talwin; a few low-level healthcare workers came up with the T’s & Blues combination, and shooting Pentazocine (which was unscheduled at the time) and Pyribenzamine (a.k.a. Tripellenamine, a common Rx cold/flu anti-Histamine of the day) spread across the country…
…Then it started: Talwin NX. Pentazocine and Naloxone, combined in one pill. To stop intravenous abuse, they said. And it did: only, abuse never stopped, it just switched to oral and insufflation. A new combination was then discovered to be adequately euphoric to abuse: Talwin NX and Ritalin. All was quiet for a couple decades, then Reckitt-Benckiser hit the lottery with their orphan drug Buprenorphine, owning the patents and branding rights for all of the Bupe products. The magic bullet that made this fortune and fame possible? Narcan. Add some, make money…

…Seriously. It worked for T’s & Blues, remember? See, Pentazocine, Buprenorphine, both partial agonists, both have a long history of IV abuse and addiction, Naloxone cured the IV Talwin problem, we will prevent IV abuse of our Buprenorphine product from ever starting by putting the Narcan in first…

..Now that two working examples of narcotic/Narcan combination products are slick deal-makers in the American Big Pharma, Federal agency shakedown game, every other mom & pop pharmaceutical company is jumping on board with a Dope/Narcan product:
OXYTREK
While not Naloxone, it’s still an antagonist, Naltrexone. Brought to us soon by Pain Therapeutics.
Oxycodone + Naltrexone in a pain relief pill.

Quote: Pain Therapeutics’ oxycodone/naltrexone combination, OxyTrek. Factors driving the market rebound will include the premium pricing of these new therapies compared with current options, most of which will be available generically by the time the new drugs are launched.

“Improving on the significant side effects of analgesics is the near-term opportunity for drug developers, as it has been for many years, and a few companies will succeed in providing incremental improvements in safety or tolerability, despite the recent dramatic changes in the regulatory landscape,” said Michelle Grady, therapeutic area director, Pain Management, at Decision Resources, Inc.

Meaning: “We’re gonna make a ton of f***ing money duping the government, the patients and the addicts”

EMBEDA

Morphine + an antagonist (which one is not known yet)

Quote: Alpharma has asked the Food and Drug Administration to approve Embeda as a tamperproof medication for patients with moderate to severe chronic pain. The pills are formulated so that the euphoric effects of morphine are blocked when a patient crushes, dissolves or chews them. Patients often abuse pain pills by grinding them up to snort or inject.

Same old story, add antagonist, dope not so good to dope fiends, no addiction, better pain management results in old people, etc …

…I don’t think I need to add the Pharmaceutical/Industrial Complex commentary on that one. Same story as Suboxone, Talwin NX and soon OxyTrek: Make a mint with a new medication to brand and have exclusive patent rights to, get great publicity and approval from the gov’t / medical authorities for making a less addictive, less abusable, abuse-resistant, etc product. Stock manipulation by slightly altering the best selling product, create a competitor for your own product, make more money on your products by making more money on your products- a brilliant plan…

…So, thats it people. First a trickle, here comes the flood.

Combination Agonist + Antagonist opioid medications are the future, thanks to Big Pharma and the crooked insider-trading-esque laws we have regarding pharmaceutical branding, patents and distribution rights. Don’t worry though, as with every other “less addictive”, “tamper-proof” pill they make, we will all still be able to abuse, shoot, snort, parachute, plug, smoke, and combine these new and yet to be developed pills and formulations.

After all, they’re counting on it, all the way to the f***ing bank.

One medication not mentioned is a new drug on the market called Relistor–  it is an interesting combination from my perspective.  My neurochemistry experiences are behind my fascination with some of these new medications– which are based on our basic understandings of opiates and the brain.  Relistor is essentially naloxone, altered by the attachment of another molecule so that the new molecule doesn’t pass through the ‘blood brain barrier’.  The result is a medication that when injected blocks the effects of opiates on the gut, without affecting opiates in the brain.  The medication is used to treat opiate-induced constipation.

As for the other products, I think that his last line summarizes the writer’s sentiment pretty well– even after I took out a few letters from one of the words!