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FDA Approves Nucynta ER for Chronic Pain

By August 28, 2011

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Nucynta ER (tapentadol extended release) was approved by the U.S. FDA on August 26, 2011 for the management of chronic pain. Nucynta ER is an oral analgesic to be taken twice daily for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is indicated for an extended period of time. The approval of Nucynta ER is based on a phase III clinical trial that evaluated the drug as a treatment for moderate to severe low back pain and diabetic peripheral neuropathy. The drug's safety was evaluated in 1,100 patients with moderate to severe chronic pain over a one-year period.

In 2008, the FDA approved Nucynta (not the extended release version) for the relief of moderate to severe acute pain. In 2010, a study that compared tapentadol to oxycodone in knee osteoarthritis patients found tapentadol was effective for pain relief with fewer gastrointestinal side effects than oxycodone.

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Photo by Doug Cannell (iStockphoto)

October 23, 2011 at 4:19 pm
(1) Steve says:

I was on Oxycontin,Hydrocodone, Delaudid, Exalgo and more but this is the only med that has put me back to work. I was ready to sign up for disability until Nucynta came along. I have aches that remain but at 50 they are normal and this is my miracle for my pain relief. Thank You all for this medication and a new lease on life.

November 4, 2011 at 7:29 pm
(2) Kim says:

Steve, would you mind saying what your symtoms were that led you to try this drug? I have just been perscribed it for chronic neck pain from 3 herniated discs, but it will not be available at my local drug store for another week.
Thank you for sharing your experience.

December 26, 2011 at 12:24 pm
(3) John says:

I just switched from Nucynta to Nucynta and the difference is amazing.

Nucynta made me dizzy, erased my short-term memory, and made it very difficult to think~to make decisions, etc. It hit me about 20 minutes after taking it and it wore off about 2 hours later.

Nucynta ER does not create any confusion, loss of memory, etc.
I feel mentally fine again. However, I’m not sure the pain relief with the ER is as dramatic as regular Nucynta.

March 26, 2012 at 12:39 pm
(4) KymBerly says:

John, I had to wrack my brain to see If I had ever posted on this site. Then I finally noticed your name. You Experience 100% is my Experience.
I started on Nucynta 50mg, then went to 75mg then from 3x a day to 4x a day, and now have been switched to the ER Forum Twice day at 200mg.

The pain relief is not as great with Nucynta ER. But even saying that it is much better than Vicodin, Oxycodone, OxyContinin Etc.

I also dealt with the Confusion and Short Term memory loss. I could walk in a room and forget what I had gone in to get.

The Nucynta ER has allowed me to get some of my memory back which is great!

I see my Pain Management Doctor today to discuss options for break through pain. We may go with Nucynta Regular since I do not need to use it very often.

March 26, 2012 at 3:36 pm
(5) Pat says:

I take Nucynta ER for my back pain and radicular pain down my leg. A week ago I was switched to Nucynta ER (200mg every 12 hours), from the 100mg Nucynta (immediate release) I was taking every 4 hours – usually 3 pills a day, never more than 4 a day though. As others reported the IR only lasted about 2 hours before wearing off. I never noticed any loss of memory with either Nucynta formulation. I do find that the ER works MUCH better at providing an even around-the-clock dosage, and now getting up in the morning is practically pain free! and THAT is an excellent benefit as ambulating upon waking and getting up for bathroom breaks during the night were often pretty painful!

June 6, 2012 at 7:30 pm
(6) Deb says:

Nucynta ER 50 twice a day has been easier on my intestinal tract than former medications. Taking with dilaudid 4mg, four times a day, also. Although this is not totally controlling the pain, it does not make feel completely unable to carry on a conversation. Osteoarthritis and RA have taken my life away, as far as being as physically active as I once was, working and traveling as I once did. This is the worst pain I have ever experienced and finding a combination that works is an ongoing problem. Have others had a good experience with Flector or Voltren?

June 25, 2012 at 3:15 pm
(7) Stuart says:

I have been taking Nucynta ER 50mg twice a day for about 1 month with some success. I am also taking Relafin 750mg once a day. The Nucynta ER has been working to an certain extent (not for the entire 12 hours, but for about 6 hours max), but the great thing is I have not had any negative side effects. I am going to be put up to 100mg twice a day to see if that will help relieve the remainig pain I have. I suffer from osteoarthritis and degenerative disc disease in my lower back. After hearing all the negative things with Oxycodone, I am glad that Nucynta ER is an alternative that so far is working and once we get to the proper dosing I am sure the pain relief will be there.

August 14, 2012 at 12:29 pm
(8) Kyle says:

I have to say this has been a miracle drug for me. I am on Nucynta ER 150mg 1 every 12 hours and NO side effects. I cant speak for everyone but if you suffer every minute of the day with pain for years, than this is something you should try. I thought I had to live with pain for the rest of my life, but now I can do the things I could before my nightmare of pain started. The only thing is the cost is way to high with or without insurance. The web site has a coupon that stats $25.00 but thats not the case. My first out of pocket was $266.00 without insurance its over $400.00 without insurance. The other problem is that you cant find it any place they dont carry it because its so new. If they order it you have to wait up to 7 days to fill it. I only wish they would lower the price and make it more available because there are people out there that this drug can help. If more Doctors knew about it and people could afford it. I will end with this, if you suffer every minute of the day in pain, than ask your Dr. if this could help you. I did for me.

September 21, 2012 at 11:51 am
(9) Angela says:

I have Pyoderma Gangrenosum ( severe leg wounds) do you think this pain medication will help mt severe pain?

November 28, 2012 at 12:57 am
(10) Liz says:

I am using the regular Nucynta during the day. (max 200mg), but I was prescribed the Nucynta 200mg ER to try. It gave me a migraine, made me dizzy and too drowsy to drive. I am thinking about using it only at night, since it is long acting, but still using a small amount of regular during the day. Anyone tried this? Any reactions? I have severe nerve & back pain pain.

December 8, 2012 at 4:56 pm
(11) Matt says:

I just started the 50mg ER in August, and I agree it’s a miracle drug. The first week was rough with a pretty bad stomach ache but it passed. With the weather getting colder I’m having a little more pain now so I take a Nucynta 50mg IR when needed. For the first time in 5 years i’m finally starting to feel normal. Thats another thing about the ER. You don’t feel a rush or a high. It’s like I didn’t even take medication. I now enjoy low to mild pain instead of being severe all the time. My pain is in the lumbar with severe radiation, and a bad knee.

March 16, 2013 at 7:21 pm
(12) Fran B says:

I suffer from RSD and I just changed from nucynta 100ER every 12 to 200ER every 12 and am having problems with a constant running nose and cough it almost I almost feel I am going through some of my mood issues I had with the withdrawal I went through when I went off of the morphene and I when on the nucyenta 50 3-4 a day. I don’t see my pain mgmt doc for another month so I will call on Monday, but will go back to the 100ER tomorrow – I don’t like the way I have felt for the last 2 weeks on this new stuff. It is making me feel worse. Any one else having these symptoms.

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