New Formulation For Oxycontin Approved By FDA

The FDA has approved a new forumlation for controlled-released Oxycontin, a powerful pain medication that is typically prescribed severe, chronic pain.   The goal of this new Oxycontin formula is to help discourage abuse and overuse of the drug.  This could be really good news for chronic pain sufferers who have doctors who are afraid to prescribe the drug because of the previous threat of misuse.  This new formula should put doctors at ease when prescribing Oxycontin and more patients who are legitimately suffering from pain should be able to get the drug.  

The new Oxycontin formulation will be created in a way that the medication cannot be crushed for snorting or liquified for shooting up.  If the new formula gets wet or someone tries to dissolve it, the drug will become gummy.  Because there is just a reformulation of the drug, the timetable for a potential generic version hasn’t changed.   More good news.

The Interstitial Cystitis Association was involved in the stakeholder teleconference FDA held on Wednesday, April 7 to announce approval of the new formulation. The ICA reports:

During that teleconference, FDA’s Bob Rappaport, MD, explained that the agency will require the company to do a postmarketing study to collect data on how much the new formulation reduces abuse and misuse of this opioid. In addition, he said, FDA is requiring a “Risk Evaluation and Management Strategy” (REMS). This REMS will be a straightforward one that applies to this drug only: a medication guide will be issued to patients, and prescribers will be required to be educated about the appropriate use of opioid analgesics in the treatment of pain.

FDA didn’t take this opportunity to issue a REMS for all opioids. That’s still open for comment from legitimate pain patients like you who need these medications. Please continue to tell FDA how important your access to these medicines is and that you don’t need more barriers to receiving them.

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  1. Don Gunnon says:

    I was established on oxycotin sevenyears agoI broke up an assault on a women and the guys partner shot me point blank in the stomach I,m missing part of my small intestin my stomach and the bullet is lodged in my spine after trying everything I was put on oxycotin I take my medicine as directed 80mg 3 times a day the new formula dose not work for me my pain is thru the roof now I guess for pepole like me there is no reliefe I don’t think I,m going to go on with this pain much longer.

  2. Kenneth Russo says:

    I was crushed with a back hoe bucket in 1997. I have 2 children and a loving wife. The only thing that keeps me going is the love of my family and oxycotin.I have never misused my meds, but am now forced to suffer b/c of the people that do!!!This is not fair, I will not die from the drug, but the pain will probably kill me now….The new formula gives me no relief.My pain is unbareable..Thanks alot FDA!!!!!

  3. I am finding the new formula is less effective than the original. As usual the people who really need the drug and use it according to the directions are the ones who suffer. The real reason the formulation changed was because of Doctors lobbying because they were getting sued. I don’t misuse my medication never have but here I am struggling from pain that was once under control.

  4. I have been in agony for 2 months now. I noticed the oxy tablets were different, but I figured the pharmacy was using a different manufacturer. I have been telling my wife that if the pain continues to increase I will have to get my back operated on AGAIN. The new formulation – delivery system- is flawed. Its a shame we have to suffer. All those impacted please inform your physicians and write a short letter to the FDA. Google the address.

  5. I have suffered with chronic pain for 20 years and in the past year found Percocet to be the only thing that helps; not only helps but basically eliminates my pain. After 6 months of a normal life my Dr. stopped prescribing it after attending a “narcotics are bad” seminar. I read more and more how these medications help but are becoming less available due to overreaction of Dr’s and law enforcement – are there no activist movements to improve this situation?

  6. Natalie Ray says:

    Just got through reading all of your comments. Im also a patient of the pain management system. I have interstitial cystitias, FM, and almost everything else that goes along with theses illnessess. My doctor has me on a Fyntenol patch along with BT meds of Norco. I’m not 100% pain free but it’s a he’ll of a lot better then going it alone. I don’t think I’d be here very long were I not be able curb some of the pain. Just a thought. It’s a long acting med givin via a patch which I change every two days. Good luck and God speed,

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