FDA Approves Oxycodone with Abuse Deterrent

FDA Approves Oxycodone with Abuse Deterrent

The Food and Drug Administration has approved a new extended release version of oxycodone with an abuse deterrent formula. The drug, which will be marketed by Purdue Pharma under the brand name Targiniq ER, is only the second opioid painkiller with FDA approved labeling that describes its abuse deterrent properties.

Targiniq combines oxycodone with naloxone, a drug that is used to reverse the effects of opioid overdose. Although designed to discourage abuse, the FDA says Targiniq can still be abused and should only be prescribed to patients who can’t get adequate pain relief from other medications.

oxycode300“Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone,” the FDA said in a statement.

The safety and effectiveness of Targiniq was evaluated in a clinical trial of over 600 people with chronic low back pain. The drug’s abuse deterrent features were tested in further studies on over 3,000 people. The most common side effects of Targiniq were nausea and vomiting.

The FDA is also requiring postmarketing studies of Targiniq to assess the risk of misuse, addiction, overdose, and death associated after long term use of over 12 weeks.

“The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” said Sharon Hertz, MD, a deputy director in the FDA’s Center for Drug Evaluation and Research.

“Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”

The FDA is under intense public and political pressure to fight the so-called epidemic of prescription opioid abuse. Over 16,500 deaths in the U.S. were linked to opioids in 2010, although recent research has questioned the validity of that estimate. According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

“We are pleased that the FDA has approved another analgesic treatment option for people with chronic pain. This is the second product in Purdue’s pain management portfolio to receive labeling from the FDA describing the product’s abuse-deterrent characteristics,” said Mark Timney, Purdue Pharma’s President and CEO.

“When prescription pain medications with abuse‐deterrent properties are accessible and used appropriately, then patients, clinicians, payers, and society can all benefit.”

Earlier this month, the FDA gave a priority review designation to Purdue’s “pure” hydrocodone painkiller, which is also made with an abuse deterrent formula. The FDA gives priority review to new drugs if they offer “significant improvements” in safety and effectiveness compared to existing medications. Purdue expects the FDA to make a decision in October.

That is the same month San Diego based Zogenix (NASDAQ: ZGNX) plans to file a new drug application for an abuse deterrent formulation of Zohydro, the controversial hydrocodone painkiller the company introduced without any tamper resistant properties.

In addition to Purdue and Zogenix, Pfizer (NYSE: PFE) and Teva Pharmaceuticals (NYSE: TEVA) are also developing hydrocodone painkillers with abuse deterrent properties.

Oxycodone is the active ingredient in OxyContin, which many addiction experts say helped fuel the rise of prescription opioid abuse when it was introduced by Purdue in 1996.

In 2007, several Purdue executives pleaded guilty to a felony count of misbranding OxyContin, by playing down its addictive side effects. The company and its executives were fined $634 million.

Authored by: Pat Anson, Editor

newest oldest
Notify of
kellix

I think its funny, Pfizer is trying to make a new form of Oxycontin, it should have gone generic like 8 years ago, but they keep changing the formulations and now from politicians saying, were not positive the generic will have the tamper resistant,. The thing it comes down to me, MONEY, how much money they have made off of it has been a fact, they don’t want the golden goose to get away. This new one here with the naltrexone, I hope it works for people that are using it correctly not like addicts. I think its fine for them to come up with things that work but if you try to abuse it, it screws you. Which I wish they thought of that years ago. But business was too good for them to care. 🙁

I think that the DEA AND the doctors and people who try to take medicine away. Why don’t you live in our shoes I have way too much to type but I’m a big time suffered to this day I still live in a lot of pain and it will never go away. You guy’s are making it worse for us but also dangerous because of drug attics

Another distressing example of what happens when we put profits before people. This is a stupid drug. It serves no purpose other than to generate income for those who sell it. It will be marketed as safer than oxycodone. It’s not. Now let’s be clear. This stupid and dangerous new drug will not cause iatrogenic addiction because fools try to inject or snort it, no. Instead, it will cause iatrogenic addiction because individuals suffering from pain (and depression and anxiety and life problems) will become addicted to it via the oral route. Because they and their doctors will believe (or tell themselves) that it’s “abuse deterrent.” Then, when their physical dependence has worsened to the point at which stronger opiates are required, they will find heroin, because heroin is (and remains) everywhere. Are we going to get real about treating addiction, people? Or are we going to keep dispensing this lethal nonsense? Clinicians have a choice to make here.

Kristine

Not everyone that takes an opiate, is faking it or are “drug seekers”. I live forevermore, with a neck fused with titanium on (4) levels. There are (8) screws now, as the first (2) level fusion fell apart, and nobody believed me. The MRI does not show a broken fusion.
I got off kadian (morphine) and oxycontin, on my own. I found a great osteopath, who helped me do this. My insurance will not pay a penny of his services and he CURED my bursitis.He did great “cranio” work on my neck, but I cannot afford him anymore.
Now I take 20mg of oxycodone 2-3 x’s a day, and I move as much as I can, ride my bike, swim and do some yoga. I function and I am not crying anymore. Not everyone snorts their meds, so throwing us all into the same pot, is wrong.
I do not feel bad about needing to take (1) pain medication, for such a horrific injury, thanks to a DRUNK DRIVER.
I did not ask for this.

I need information on the best product to take care of back pain or hip pain. I have oxycotin and oxydodine

I don’t understand the new Oxycodine plan.
I take oxycodone and oxycotin.
I need them both to make it thru the day.
Is the new plan better ????

I was on oxycontin, oxycodone for years due to the severe pain I’m in constantly. Not once was I addicted to it. In fact, I stopped taking it cold turkey because a new pain clinic doc asked me to. All that did was cause so much pain I wanted to die. I had to switch to morphine, and it doesn’t provide nearly the relief I had with the oxy. I have quit going anywhere and don’t even leave my house since then, due to the pain. It’s been at least 2 years now. Walmart won’t accept oxy as part of their plan, therefore I suffer more. Tell me that’s fair.

I had a Medial Branch Block on my back yesterday.
I don’t feel any relief yet.
I have another one on August 6th.
Is this going to help the pain on my right thiegh????

I have no problems with Osycotin or Oxycodone.
I feel great and do not need to use more than the Dr prescribes.
That is bad to hear!

BL

Wasn’t there another drug a number of yrs ago that they added naloxone to as a abuse deterent and it made the drug ineffective ?