I find that difficult to believe. If my skin can extract the drug I'm sure some enterprising bright fool will find a way to replicate that process in a laboratory. Wonder what happens if some druggie uses the patch in random orifices?
Posted on 12/26/2011 3:02:28 PM PST by E. Pluribus Unum
Drug companies are working to develop a pure, more powerful version of the nation's second most-abused medicine, which has addiction experts worried that it could spur a new wave of abuse.
The new pills contain the highly addictive painkiller hydrocodone, packing up to 10 times the amount of the drug as existing medications such as Vicodin. Four companies have begun patient testing, and one of them — Zogenix of San Diego — plans to apply early next year to begin marketing its product, Zohydro.
If approved, it would mark the first time patients could legally buy pure hydrocodone. Existing products combine the drug with nonaddictive painkillers such as acetaminophen.
Critics say they are especially worried about Zohydro, a timed-release drug meant for managing moderate to severe pain, because abusers could crush it to release an intense, immediate high.
"I have a big concern that this could be the next OxyContin," said April Rovero, president of the National Coalition Against Prescription Drug Abuse. "We just don't need this on the market."
OxyContin, introduced in 1995 by Purdue Pharma of Stamford, Conn., was designed to manage pain with a formula that dribbled one dose of oxycodone over many hours.
Abusers quickly discovered they could defeat the timed-release feature by crushing the pills. Purdue Pharma changed the formula to make OxyContin more tamper-resistant, but addicts have moved onto generic oxycodone and other drugs that do not have a timed-release feature.
Oxycodone is now the most-abused medicine in the United States, with hydrocodone second, according to the Drug Enforcement Administration's annual count of drug seizures sent to police drug labs for analysis.
The latest drug tests come as more pharmaceutical companies are getting into the $10 billion-a-year legal market for powerful — and addictive — opiate narcotics.
"It's like the wild west," said Peter Jackson, co-founder of Advocates for the Reform of Prescription Opioids. "The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public."
The pharmaceutical firms say the new hydrocodone drugs give doctors another tool to try on patients in legitimate pain, part of a constant search for better painkillers to treat the aging U.S. population.
"Sometimes you circulate a patient between various opioids, and some may have a better effect than others," said Karsten Lindhardt, chief executive of Denmark-based Egalet, which is testing its own pure hydrocodone product.
The companies say a pure hydrocodone pill would avoid liver problems linked to high doses of acetaminophen, an ingredient in products like Vicodin. They also say patients will be more closely supervised because, by law, they will have to return to their doctors each time they need more pills. Prescriptions for the weaker, hydrocodone-acetaminophen products now on the market can be refilled up to five times.
Zogenix has completed three rounds of patient testing, and last week it announced it had held a final meeting with Food and Drug Administration officials to talk about its upcoming drug application. It plans to file the application in early 2012 and have Zohydro on the market by early 2013.
Purdue Pharma and Cephalon, a Frazer, Pa.-based unit of Israel-based Teva Pharmaceuticals, are conducting late-stage trials of their own hydrocodone drugs, according to documents filed with federal regulators. In May, Purdue Pharma received a patent applying extended-release technology to hydrocodone. Neither company would comment on its plans.
Meanwhile, Egalet has finished the most preliminary stages of testing aimed at determining the basic safety of a drug. The firm could have a product on the market as early as 2015 but wants to see how the other companies fare with the FDA before deciding whether to move forward, Lindhardt said.
Critics say they are troubled because of the dark side that has accompanied the boom in sales of narcotic painkillers: Murders, pharmacy robberies and millions of dollars lost by hospitals that must treat overdose victims.
Thousands of legitimate pain patients are becoming addicted to powerful prescription painkillers, they say, in addition to the thousands more who abuse the drugs.
Prescription painkillers led to the deaths of almost 15,000 people in 2008, more than triple the 4,000 deaths in 1999, the Centers for Disease Control and Prevention reported last month.
Emergency room visits related to hydrocodone abuse have shot from 19,221 in 2000 to 86,258 in 2009, according to data compiled by the Drug Enforcement Administration. In Florida alone, hydrocodone caused 910 deaths and contributed to 1,803 others between 2003 and 2007.
Hydrocodone belongs to family of drugs known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, methadone and hydromorphone.
Opiates block pain but also unleash intense feelings of well-being and can create physical dependence. The withdrawal symptoms are also intense, with users complaining of cramps, diarrhea, muddled thinking, nausea and vomiting.
After a while, opiates stop working, forcing users to take stronger doses or to try slightly different chemicals.
"You've got a person on your product for life, and a doctor's got a patient who's never going to miss an appointment, because if they did and they didn't get their prescription, they would feel very sick," said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. "It's a terrific business model, and that's what these companies want to get in on."
Under pressure from the government, Purdue Pharma last year debuted a new OxyContin pill formula that "squishes" instead of crumbling when someone tries to crush it.
But Zogenix, whose drug is time-released but crushable, says there is not enough evidence to show that such tamper-resistant reformulations thwart abuse.
"Provided sufficient effort, all formulations currently available can be overcome," Zogenix said in a written response to questions by The Associated Press.
At a conference for investors New York on Nov. 29, Zogenix chief executive Roger Hawley said the FDA was not pressuring Zogenix to put an abuse deterrent in Zohydro.
"We would certainly consider later launching an abuse-deterrent form, but right now we believe the priority of safer hydrocodone — that is, without acetaminophen — is a key priority for the FDA," Hawley said.
FDA spokeswoman Erica Jefferson said the agency would not comment on its discussions with drug companies, citing the need to protect trade secrets.
Drug control advocates say they're worried the U.S. government is too lax about controlling addictive pain medications. The United States consumes 99 percent of the world's hydrocodone and 83 percent of its oxycodone, according to a 2008 study by the International Narcotics Control Board.
One 41-year-old loophole in particular has fed the current problem with hydrocodone abuse, critics say. The federal Controlled Substances Act, passed in 1970, puts fewer controls on combination pills containing hydrocodone and another painkiller than it does on the equivalent oxycodone products.
A Vicodin prescription can be refilled five times, for example, while a Percocet prescription can only be filled once.
The Drug Enforcement Administration and Food and Drug Administration have been studying whether to close this loophole since 1999 but have made no decision. Congress is now considering a bill that would force the agencies to tighten the controls.
"This is a problem that is fundamentally an oversupply problem," said Jackson, the drug-control advocate. "The FDA has kind of opened the floodgates, and they refuse to recognize the mistakes made in the past."
Pure hydrocodone falls into the stricter drug-control category than hydrocodone-acetaminophen medications, meaning patients would have to go to their doctors for a new prescription each time they needed more pills. But Jackson said that's no guarantee against abuse, noting that dozens of unscrupulous doctors have been caught churning out prescriptions in so-called "pill mills."
The Drug Enforcement Administration, which enforces controls on medicines along with the FDA, said it could not comment on drugs that have not yet been approved for sale.
However, Zogenix has acknowledged the abuse issue could become a liability.
"Illicit use and abuse of hydrocodone is well documented," it said in a filing with the Securities and Exchange Commission in September. "Thus, the regulatory approval process and the marketing of Zohydro may generate public controversy that may adversely affect regulatory approval and market acceptance of Zohydro."
When I blew the hell out of my knee, hydrocodone wouldn’t hardly even touch the pain. They finally had to put me on oxycodone in order for me to be able to do any physical therapy.
Oxycodone completely killed the pain and put me on an extremely pleasant high. It made my rehabilitation possible, but it was a good thing when the prescription ran out. I was enjoying it too much.
We’ll see ‘bout all that.
Legislation would mandate check before writing prescriptions
I am aware of the legislation. Last year congress was debating to remove some pain med’s completely from the market.
I receive my med’s from the VA, and before prescribing I was asked to sign three contractual forms informing me I could be drug tested at their request on any given day. They also informed me there is in place in Tn. a data base on pain meds’ to prevent DR. shopping. I signed the documents, I have no problem with this. As I stated, “I take as prescribed by the DR”. I see the drug abuse with-in my home district and it isn’t pleasant in any form.
All’s well that ends well. We are really on the same team. Best wishes, grumpygresh.
I too take a drug on the hit list and have for 17 years. I take Xanax for some sensory processing disorders & related seizure control. It helps too tone down my sensory system. It took me almost two years too find a doctor who would agree to writing it for me long term thanks to the scaremongering. My wife has taken same medication for 26 years safely.
By the book protocol medications nearly killed her and me because protocol medication was antidepressants which to some persons like me and her can have the same effect as taking LSD.
I went to a V.A. clinic to keep in their system for hearing aids. A doctor there who did not know me from Adam nor any of my history as such within 5 minutes wanted to immediately change my medication. I said NO! I told him how long I had taken it safely and it worked just fine. I was not going through the hell again I had gone through earlier. Government is treading into an area where it can do the most harm which is in a doctors exam room second guessing their decisions.
Government uses scaremongering to create an artificial crisis. The drugs they mention many of them in 1880 were sole OTC no prescriptions needed. They were either sold in stores or occurred in nature. Prohibitions and the War On Drugs and everything else has created major crime and corruption the same way prohibition of alcohol did in the 1930's.
The prohibitions make the illicit use the forbidden fruit so to speak. My position on the W.O.D. over the past couple of years has evolved to legalization so the market falls out of the illicit drug trade and the bad stuff made by Bubba like METH is stopped. METH Labs are also a by-product of the War ON Drugs. The War on Drugs to try and stop the impossible has evolved to a War ON You and Me with our Constitutional Rights & Protections taking a distant back seat and the Fourth Amendment protection becoming Nil. In the mean time it has not slowed down illicit manufacturing nor even the illicit drug flow from Mexico from the Cartels who love our W.O.D..
A little bit more interesting history. If you look back in history drugs like Cocaine have always been available and were even consumed in the time of the nations founding. They had pricey little {snuff} containers in the form if rings, small tins, etc which basically held a dosage. In much the same way alcohol was used by man for mankind's entire history the U.S. prohibition made consumption skyrocket. Bars popped up everywhere. The stuff on the streets many times was not safe. Persons like Joe Kennedy SR made a fortune and did many others like Chicago Mobs.
In today's world and in our state an LEO on his gut feeling can confiscate your personal property if drugs are suspect. This can simply mean a dog hits and you have a substantial amount of cash on you which is also not illegal. Government in the name of the W.O.D. can take it and you pay hell getting it back. A couple of counties near Knoxville developed bad reputations using this practice.
In no way do I advocate, condone, nor encourage anyone to use drugs other than for medical need. But if a persons wants to waste their brain by abuse of such there is no law short of permanent lock away that can stop it and it doesn't even work in prison where despite government control usage and trade is rampant. If government can't even stop it in guarded prisons why should any reasons person seriously believe government can stop it otherwise? It can't but governments including federal, state, and local, are making a vast fortune on taking property including cash, vehicles, and even homes all in the name of the War on Drugs.
The War on Drugs is an illicit partnership a gentleman's business agreement of cat and mouse between cartels and government that reaches all the way into the top offices of government. Next will be persons who dare mention this is happening will be persecuted by the government as well or placed on a list in a database. I was the one in the comments section of the article who posted The words of Ronald Reagan come to mind. The nine most terrifying words in the English language are, 'I'm from the government and I'm here to help.' and this one "I don't believe in a government that protects us from ourselves." Ben Franklin IIRC is credited with a saying about ones exchanging liberty for security deserve neither.
I think with every RX for this and other narcs a doc writes he must also give instructions on weaning and something to wean off on if this is possible
Like they couldn't put that on the label?
Like anybody would pay attention to it?
Has the warning on a pack of cigarettes ever stopped somebody from smoking?
I had a similar experience. Unable to go #2 ... thought I was going to have to go to the ER for “relief”.
Big Brother is in the exam room. Big Insurers put Big Brother there too protect their Big Profits just like most Nanny State laws on the books in the past 40-50 years. What disgust me the most is GOP Lawmakers are Enablers to this sort of tyranny.
I find that difficult to believe. If my skin can extract the drug I'm sure some enterprising bright fool will find a way to replicate that process in a laboratory. Wonder what happens if some druggie uses the patch in random orifices?
How can that possibly be without some time of feedback system? I see no evidence of any feedback loop in the TPM/matrix delivery product. Instead of taking 10 days to get to the maximum therepeutic dose it would take 1/3 - 1/4 as long.
Believe it or not, it makes no difference to me. The proof will come in time as this products is commercialized and put into use. BTW, it makes no difference what “orfice” the druggie may try to stuff the patch into. That’s laughable.
I credit you with at least doing some research. However despite that you have reached an incorrect conclusion, partly based on looking at some very old clinical trial results. It no longer takes 10 days to reach a therapeutic dose - now it is about 24 hours due to improvements in the patch configuration between early experiments and the development of the final commercial configuration.
As for your feedback comment, you are right, and the feedback is essentially the same as it is in any equilibrium situation. Once the therapeutic dose is achieved, the patch releases only enough active to replace the drug as it is metabolized.
The rate the drug migrates through the skin is dependent on the gradient. As plasma concentration rises, the rate of migration through the skin drops.
Maybe you’ll just have to take my word for it at least for now.
They gave that to my daughter in the hospital. She enjoyed it a little too much. It worried me.
Oxy is more potent than Hydro. You probably took too high a dose.
Too strong of a dose. She would have been better off taking a low dose of pain killer simultaneously with an anti-inflammatory.
(I've been around people in pain entirely too much.)
She said she wasn’t in a lot of pain, not enough to take such a strong narcotic,that is. It obviously hurt but I believe she took an over-the-counter pain reliever.I think she took Aleve.
I know OxyContin was/is prescribed to cancer patients. Our doctor(she and I have the same one)will not prescribe it. That’s far too stong. I’ve never had a broken bone and I know it hurts like hell but OxyContin? Maybe if you broke multiple bones.
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