FDA Decision Could Mean More Tamper Resistant Painkillers

FDA Decision Could Mean More Tamper Resistant Painkillers

downloadAn FDA decision to block a generic version of OxyContin from coming on the market is a “clear mandate” that other opioid painkillers will have to be made tamper resistant, according to the head of the German pharmaceutical company that developed the technology that makes it harder for pills to be crushed and abused.

“My personal view is this is a precedent on how the FDA will move on other (drug) molecules,” Harald Stock, CEO of Grunenthal Group, told the National Pain Report.

Grunenthal has licensed its abuse-deterrent technology to Purdue Pharma, which began using it in OxyContin in 2010.

On Tuesday, the Food and Drug Administration approved new labeling for OxyContin stating that the reformulated version of the painkiller is harder to crush or dissolve and reduces chances of abuse. It’s the first time the FDA has recognized the effectiveness of a tamper-resistant product.

“The FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and (is) expected to reduce abuse by snorting compared to original OxyContin,” said Douglas Throckmorton, MD, deputy director for the FDA’s Center for Drug Evaluation and Research.

The FDA decision effectively ends any chance that cheaper, generic versions of OxyContin will come on the market until 2025, when Purdue’s patent on the reformulated version ends. Analysts say generic OxyContin, which is the brand name for oxycodone, would cost about 30% less and be more affordable to pain patients.

Harald Stock, CEO of Grunenthal Group

Harald Stock, CEO of Grunenthal Group

Stock believes that once his company’s abuse-deterrent technology is more widely adopted and more opioids are made tamper resistant, doctors will feel more comfortable prescribing the drugs and pharmacies more willing to dispense them.

“I think it’s a landmark decision for pain patients because it lifts restricted access to innovative pain medications,” Stock said. “With a clear mandate to do whatever is technically possible to avoid abuse, this allows those who are really in need of pain medication to get access to them. And maybe the hesitancy of the prescribers is less high.”

Grunenthal uses a polymer to make pills harder for drug abusers to crush and snort. If they try to dissolve the pills for injecting, they turn into a useless gel.

In addition to Purdue’s OxyContin, Grunenthal’s tamper resistant technology is also licensed to Endo Pharmaceuticals, which uses it in Opana, another powerful painkiller. Grunenthal receives a royalty from the drug makers for each pill sold.

Some pain patients believe the tamper resistant drugs are not as effective or make them sick.

“From my experience with (OxyContin), it does not work nearly as well for pain as it once did. I can honestly say it does not last 12 hours,” says Donna Ratliff, a pain patient and patient activist in Florida.

“I have heard many patients say that it upsets their stomachs because of the weird gummy substance that is contained in it.”

Another patient said it took her a couple of months before she realized the OxyContin she was taking was different.

“During those months, I became increasingly sick with terrible GI (gastrointestinal) upset, headaches, anxiety, increased pain, sleeplessness, irritability, vomiting etc. After my doctor called my pharmacist, we figured out that it was the new formula that was making me sick,” said Nancy, a pain patient in Massachusetts. “Since going off of the new formula, my symptoms have improved, but my pain has never been as well controlled as it was on the original OxyContin formula.”

“I continue to be amazed at how all these changes are made to improve the health & well-being of the people who shouldn’t be taking these medications to begin with.  The people who actually benefit from them, and use them properly, can have their lives ruined by these ‘formula changes.’”

Grunenthal’s Stock told National Pain Report the company had only seen “anecdotal evidence on your website” of people getting sick. He said adverse reactions to painkillers, such as nausea and an upset stomach, were common for opioids.

“The mode of action of the technology that makes it tamper resistant is not bioactive,” he said. “The technology that makes the pill hard and makes the pill gel has no effect whatsoever on your body. It’s inert.”

Authored by: Pat Anson, Editor

There are 6 comments for this article
  1. Mark S. Barletta at 11:56 am

    The original formula of OxyContin was a miracle medication for me, it was the first medication to get my never ending chronic pain under control back in 1999.
    I was on the Purdue Patient Assistance program and was receiving it free of charge ,all I needed to do was send in the script in the envelope Purdue Pharma sent to me with each refill of Oxycontin. This went on for 5 years then Medicare part D. came out and the Purdue Patient Assistance program came to a end for me. So my doctor switched me to something different besides my body was becoming tolerant to the same dose of OxyContin and it was time for a opioid rotation.

    This was around the time the new reformulated OxyContin came out and I had several friends that still took OxyContin and everyone of them said the new formula was making them sick to their stomach. They said this gummy substance was in their stool.
    So making a time released medication is one thing, making it abuse deterrent is another thing. I don’t think people that suffer from chronic pain should have to pay the price for those that abuse these medications. So making these medications to where abusers cant crush them and abuse them is taking away from the real reason why these medications are formulated.

    Regards,
    Mark S. Barletta

  2. E11 at 8:16 am

    I was switched to the abuse proof medication back in 2010, one of the worst months I remember. Not only was my pain not managed effectively, something in the new plastic formula caused horrific migraines that were very difficult to get under control.

    I was switched to another medication and the migraines stopped. Again, we, chronic pain patients have to suffer, with even more limited access to pain relief, with who knows what kind of long term damage that formula could cause, because of those that break the law.

  3. Christina R at 8:56 pm

    If they are not going to allow a generic for oxycontin then purdue should be forced to reduce the prices. They are ridiculously expensive and do not last as long as they claim. They do upset your stomach and physician on the advisor board or pharmaceutical companies will claim there safe and do not cause any more upset then all opiate medications. Politics needs to be taken out of the decision that are being made and back to the benefits of why these medications were created. I was happy to hear the Minster in Canada say they based their decision on Not blocking generic on science Not political parties. This is what we should be doing and not making decisions on out of dated information and private political parties. I’ve been on pain management since 2003 and I have not overdosed or misused my medication. I take my drug test keep my blood work up to date and MRI’s. Yet I am forced to go without my medications for weeks at a time and I feel it’s wrong on so many levels. I have been looking up were the DEA get there quotas from and the information is so old that they are using. Something has to change for pain patients because we are just as important as people who have heart conditions, diabetes, depression. We are put at the bottom of the list of importance in the health industry. We need to ban together and write the human rights department and tell of how our rights are being violated by the government. How we are all labeled as junkies and need everything tamper proofed. What they fail to except in my opinion is if someone wants to abuse something they will. You will not stop them all its doing is hurting the patients that are legitimate. I feel like they don’t think or care how it will effect legitimate patients. They need these medications to have any kind of life other then laying on the bed or couch. You don’t have to have cancer to be in PAIN. There are alot of conditions that cause violent pain.

  4. D Ratliff at 12:25 pm

    AMEN to number 2 anonymous! It is very true that you can Google it and find many patients all claiming the same statements. It’s great for Grunethal because he is making BIG BUCKS on each pill sold but for Purdue and Endo, they are losing tons of money because a whole of patients have stopped using their products because of the gummy substance. If it makes the FDA and DEA happy and they think it will deter addicts? They are wrong. Just Google how addicts are getting around the formula.
    So who is this helping now? It sure isn’t the legitimate pain patients. Isn’t that why they created this time release med anyway? Besides.. Who says an addict can’t take 4 or 5 pills at time?
    As for all chronic pain patients? You are screwed by your own government because they don’t care about YOU! They only care about the minority who are addicts.

  5. Fred Brown at 8:27 am

    It is too bad that the FDA will not let the generic copy be made with the abuse-deterrent technology. It’s a wonderful medication for chronic pain patients living with severe pain.

    Many other decisions that have been made by both the FDA and the DEA have made it very difficult for legitimate pain patients to obtain their medications. MUCH MORE DIFFICULT. I in no way put down these two agencies as they have done very positive things for the public. I as a long term chronic pain patient would like to see some type of way that the public is protected but at the same time, we patients are able to obtain our medications without feeling like we have done something wrong.

  6. Anonymous at 6:00 pm

    Thanks for the great article Mr. Anson. All anyone has to do is Google “New OxyContin Formula” or anything related to it, and MANY stories will appear about the ineffectiveness, side effects (especially GI problems), and problems with the Tamper-resistant formula.

    People know the difference between nausea & stomach upset from opioids (symptoms that essentially ALL opioid tolerant patients no longer have) & GI upset and severe pain from a plastic glue in the new tablets.

    To say that the new technology or formula has NO effect whatsoever on your body is simply untrue. People with severe pain don’t need any additional pain and symptoms CAUSED by the very treatment that is supposed to make them feel better. That is the experience of many people who took the newer formula. Period!