FDA: Pain Patients Dependent On Opioids Are Not Addicted

FDA: Pain Patients Dependent On Opioids Are Not Addicted


The U.S. Food and Drug Administration has released new guidance to drug makers to streamline the development of buprenorphine products to treat opioid addiction. Commonly known by the brand name Suboxone, buprenorphine has long dominated the market for addiction treatment.

Of importance to pain patients is a statement about the guideline by FDA commissioner Scott Gottlieb, MD, that seeks to clarify the difference between opioid addiction and patients who need opioids for pain relief.

Gootlieb said there is still stigma and misunderstanding – even in the medical and addiction fields – about the difference between opioid addiction and dependence.

“Because of the biology of the human body, everyone who uses a meaningful dose of opioids for a modest length of time develops a physical dependence. This means that there are withdrawal symptoms after the use stops,” Gottlieb said. “A physical dependence to an opioid drug is very different than being addicted to such a medication.


“Addiction requires the continued use of opioids despite harmful consequences on someone’s life. Addiction involves a psychological preoccupation to obtain and use opioids above and beyond a physical dependence. But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

“Someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

— Dr. Scott Gottlieb, FDA Commissioner

In recent years new and generic formulations of buprenorphine have been released in tablets, sublingual films, injections and implants, and the FDA is trying to promote the development of more of them.

The guidance released by the agency basically tells drug makers they may be able to submit new drug applications for buprenorphine products without conducting the safety and efficacy trials that are usually required for other medications.

“The guidance we’re finalizing today is one of the many steps we’re taking to help advance the development of new treatments for opioid use disorder, and promote novel formulations or delivery mechanisms of existing drugs to better tailor available medicines to individuals’ needs,” Gottlieb said. “Our goal is to advance the development of new and better ways of treating opioid use disorder to help more Americans access successful treatments.”

There are currently only three drugs approved by the FDA for medication-assisted treatment (MAT) – buprenorphine, methadone and naltrexone. Physicians wishing to prescribe buprenorphine to patients must have a special certification from the DEA and are limited in the number of patients they can treat.

Buprenorphine is an opioid that is also used to treat pain. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse.

Some addicts have discovered that buprenorphine can also be used to get high or to ease their withdrawal pain from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. in 2014. 

4 Responses

  1. Doctors can prescribe buprenorphine without a special certification and can treat as many patients with it as they want if they right it as off label for pain. I’m helping two of my friends now switch from oxycodone to butrans because oxycodone is becoming increasingly more difficult to obtain here in Montana. The pharmacy’s here are now saying they are out of them or that they just don’t get them in anymore. The insurance is starting to give them issues as well so instead of becoming left in the wind they decided to do somthing before they have to suffer withdrawal and pain because one day there isn’t a single pharmacy within miles who will help them. My first friend has made the switch and says she feels better than when she was on the oxycodone and my second friend is on her way to the doc next week. It can help if your genetic make up is ok with it. Now as far as how great and safe it is, I don’t know about all that. The effect on the respiratory system is better and that is good but I don’t think it’s any less addictive and it certainly causes dependency all the same. Follow the money.. the powers that be have interest in addiction medication and rehab centers then this is what they will push and it sucks. But for now it’s the hard choices we have to make to get some relief. They back us into a corner. How many years from now will they say buprenorphine is bad and now we should take this new whatever they want us to take.. especially if they are fast tracking to get it out there by not requiring the safety and efficacy trials that are usually required. I know it’s a drug that has been around but aren’t they kinda making the same mistakes by fast tracking something else they aren’t sure of? Why can’t we make our own decisions as chronic pain sufferers with documents conditions, especially now that they know the CDC numbers were BS regarding us. It’s all about money and it blows.

    • Write it not right it..

    • Buprenorphine has all the same potential problems as any other opioid (look at the detailed product insert & compare it to any other, like hydrocodone, etc). You’re right; it not only can be abused, it’s becoming the ‘in’ drug to abuse. Moreover, it has a problem that others don’t; once a patient starts on it, even if it’s for pain, the possibility of them ever getting out from under a diagnosis of SUD non-existent.

      I know it’s getting nearly impossible to get real pain meds anywhere; i lost mine last week. But once one gets that SUD on their records, they’re pretty much screwed forever. Just another nightmare to add to our collection…as if we needed another one.

  2. Holy God, the FDA/Gottlieb actually said something that’s unequivocally true…Satan must be handing out the ice skates. And they admit buprenorphine is a street drug…I’m stunned.

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