Nucynta ER Approved For Moderate To Severe Chronic Pain Control
Editor's ChoiceMain Category: Pain / Anesthetics
Article Date: 27 Aug 2011 - 17:00 PDT
'Nucynta ER Approved For Moderate To Severe Chronic Pain Control'
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An oral painkiller called Nucynta ER (tapentadol extended-release tablets), has been approved by the U.S. Food and Drug Administration (FDA), Janssen Pharmaceuticals, Inc. announced. The medication is designed to be taken twice daily for the control of moderate to severe chronic pain in adults when a continuous, 24-hour opioid analgesic is needed for an extended period. The immediate-release version of Nucynta was FDA approved in 2008 for the treatment of acute pain in adults aged at least 18 years.
Nucynta ER is available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.
Data from the Centers of Disease Control and Prevention and the American Pain Foundation indicate that over 42 million Americans aged 20 and over suffer from chronic pain, although nobody knows what the exact prevalence is. Chronic pain is the most common cause of long-term disability, and approximately one-third of all Americans will experience severe chronic pain at some stage in their lives.
However, a study published by the American Pain Society suggests that despite treatments already available, patients are still in serious need of further therapies to help manage their pain properly and appropriately.
Chronic pain means long-term pain, while acute pain is short term.
Paul Chang, M.D., Vice President, Medical Affairs, Internal Medicine, Janssen Pharmaceuticals, Inc. explained:
"In clinical trials, Nucynta ER demonstrated proven efficacy for treating moderate to severe chronic pain. We are pleased with the FDA's decision to approve Nucynta ER as it represents an important new option to help people with chronic pain."
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Grünenthal GmbH conducted a double-blind, randomized, active-and/or placebo-controlled phase 3 investigation. They also evaluated the safety profile of the drug with over 1,100 participants with moderate to severe chronic (long-term) pain over a 12-month period. Nucynta ER was found to be safe and effective - the trial researchers also reported a favorable tolerability profile as well as discontinuation rates.
Sunil J. Panchal, M.D., President, National Institute of Pain, said:
"Chronic pain is difficult to manage, and even with the treatments available today, it can be a challenge to balance pain relief with a patient's ability to tolerate the medicine. People with chronic pain will continue to need additional options, so an approval like this is welcome news for this community and the people who suffer from this often debilitating condition."
To support the appropriate and effective management of chronic pain, Janssen Pharmaceuticals Inc. believes it is also essential to support educational programs about the safe and responsible use of pain medicines and the prevention of inappropriate use.
There is a risk of abuse with Nycynta, a long standing opioid medication. Users run the risk of becoming physically and psychologically dependent on the medication. Opioid medications, when crushed, have the potential for abuse. Drug companies say they have been trying to make more abuse-resistant opioids.
Nycynta contains tapentadol, a Schedule II drug - a category of medications considered to have a high potential for addiction or abuse, but at the same time have legitimate clinical use. Other medications in this category include methadone, morphine, cocaine, oxycodone, alphaprodine and pentobarbital.
Nucynta is contraindicated for individuals with paralytic ileus, acute or severe bronchial asthma, hypercapnia in unmonitored settings or when there is no resuscitative equipment, and significant respiratory depression. Patients using monoamine oxidase inhibitors (MAOIs) and those who have used them within 14 days should not take Nucynta because of the possible additive effects on norepinephrine levels, which raise the risk of cardiovascular events.
Both Nucynta ER and Nucynta are available by prescription only.
Nucynta ER is not a use-as-needed medication, it is not intended for the treatment of postoperative or acute pain, it should be swallowed whole and not broken, split, chewed, dissolved or crushed - doing so raises the risk of life-threatening rapid release of tapentadol. Do not consume alcoholic drinks when taking Nucynta ER.
Written by Grace Rattue
Copyright: Medical News Today
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26 May. 2012. <http://www.medicalnewstoday.com/articles/233459.php>
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Visitor Opinions (latest shown first)
Where to purchase the medication
posted by Gi Gi Randle on 24 Jan 2012 at 1:58 pmNot sure if what state you are in, but if you can find a (Mom & Pop) for lack of a bettter word, a non chain drug store. Like a neighborhood pharmacy that do compound drugs, they can get it. normally it is in stock or they can order it and it will be in store within 24 hrs.
Nucynta and Fibro Pain
posted by MB on 8 Jan 2012 at 10:49 amNucynta is the only pain medication I can take without violent episodes of vomitting. I was introduced to it when I underwent a cervical spinal fusion in July of this year. At first it seemed to work great, however, now I have been diagnosed with polymyalgia rheumatica. I have recently been experiencing rapid heartbeats and severe muscle spasms... heart rate up to 140 bpm... This is the only pain med I have been able to stomach....I am sad that I am now experiencing these side effects.
Nu to Nucynta
posted by Sam on 21 Dec 2011 at 12:04 pmI went to Wal-Mart and they ordered it. Unlike the vicodin, this seems to not have such a "high" to it. It does not work for as-needed, and when 6 hrs approaches I start to get nauseated. Hmmmm...I wish I wasn't on any pills...
Helps with morning fibro pain
posted by Joe on 9 Dec 2011 at 11:15 pmI have fairly severe fibromyalgia. I was waking up at 4, 4:30, 5 am....etc, with pain in my back and legs. I told my Rheumatologist that I wanted something time release so I'm not in pain while sleeping. He prescribed Nucynta ER. It definitely has helped the pain.the only problem I have is rapid pounding heartbeat at times since starting it 2 weeks ago. I also take pristiq, so it is probably the combined norepinephrine reuptake inhibitor action of the combined meds causing it. Savellla, an SSNRI did the same thing, but much worse. I'd say it has few side effects at all, but take note about the SNRI activity Nucynta has. I may have to ask him for some other med. I've found that oxycodone has always worked great for me, so I hope my doc will consider moving me to an ER Oxycodone med. In my opinion, at least for me, nothing knocks out my fibro pain AND fatigue/flu-like symptoms better than oxy. As for the hillbilly heroine comment, that was just moronic. People who abuse pain meds deserve to be punished, but those who need it should not be. One day you will be glad to get some "hillbilly heroine". Your time will come. You will experience chronic and/or acute pain in your lifetime. I have a wife and new son to take care of. Would you rather I take pills for fibro or would you rather pay my disability payments?? It's shocking how ignorant people are about fibro too. If you have a family member or friend with it, don't criticize them for taking pain meds. It's the only thing giving their lives back.
Look For Smaller Pharmacies
posted by ErinENj on 28 Nov 2011 at 11:42 pmWhen you're trying to find this kind of medication, don't overlook the smaller non-chain pharmacies. I took all of my scripts to Walgreens for years, but when I was put on Opana ER, I had tons of trouble getting Walgreens to keep it in stock, so I would end up having to go without my meds for a day or two at least. It was a nightmare. I tried a small, family-owned pharmacy that has been in business for more than 30 years. Not only did they have it in stock, they were willing to keep it in stock for me.
I have found that the small pharmacies are so much better. They're willing to work with you to get you the meds you need. I've been a customer there for more than a year, and they all know me by name and face - it's almost like walking into a group of friends. Plus, if they have to order something, it only takes them a day to get it. I've found that they treat me so much better than the big chains and that getting my medications, even the hard to find ones, is so much simpler and significantly less frustrating than before. So if you're having trouble finding the Nucynta, try a smaller pharmacy. They may be able to help you better than the big ones who care more about their policies than their patients.
Almost no side effects
posted by ErinENj on 27 Nov 2011 at 12:26 amI've been on 240mg of Opana ER for more than three years, and have been suffering from intense sweating, and other significant side effects. My pain doctor just tried me on Nucynta ER, and I am amazingly impressed. I had no appreciable side effects and it got rid of all of the negative side effects that I had while on Opana ER. I am so glad to find a new medication to try, as I have tried every other long-acting pain medication on the market without much success. The Opana worked really well for my pain, but the side effects gradually worsened and have gotten unbearable. I'm really looking forward to not having to deal with those effects again! This medication shows a lot of promise!
nucynta results
posted by mark james on 9 Nov 2011 at 7:28 ambeen using nucynta fast relief for about a year. works for me. had a tumor removed from sinal cord 2 months ago. this drug is good as it has less side effects then most pain medications. best one i have used. i have used all but methdone.
Pharmacy for ER version Nucynta
posted by Heather on 18 Oct 2011 at 12:55 pmI have been prescribed the ER version but I cannot find a pharmacy who carries it or is willing to order it. I've now contacted all of the major pharmacy chains around me. I would love to know if anyone knows of a major pharmacy chain that carries it in inventory.
pain
posted by heather on 14 Sep 2011 at 12:55 pmI just started nucyenta er 200 mg today. I was on 5mg of Methadone 3 x's day and my pain was perfectly controlled. Now I am nucyenta er and the reason why they switched me because I have having severe constipation and nucyenta is supposed to be "gentler" on the stomach. So I dont know, this is day one so wlll see how it goes ----so far so good!
Chronic pain
posted by Doctorpain on 5 Sep 2011 at 5:55 amThe perfect candidate. It started slowly, I started having aches body wide. It hurt to just have someone rub against my skin. My Fibro entered my life at the most depressing and upsetting time. Loss of my job, boyfriend, death of my father, many family illnesses and deaths, putting down my beloved dog, Noelle, probably made my friend thought I had lost desire for him. The pain intensified. No one seemed to understand and seemed to think I was just a chronic complainer. It seemed a no-win situation. Every day became a genuine struggle just to get out of bed, get dressed, and go to my physically demanding job. There was certainly no understanding on the job front, as everyone was required to pull their own weight, which I totally understood. Eventually, I became unable to work and left the job place feeling utterly defeated and wondering how I was going to support myself. I might add that the painkillers (Vicodin, hydrocodone,lortab) that did provide some relief were not allowed on the job site, so there appeared no solution. To make my already long story shorter, I have had to apply for social security disability. As of this date, no determination has been made. In the meantime, I receive food stamps, have sold possessions, have had to rely somewhat on family and friends. Of course, most families and friends can only supply so much support. Therefore, I have put my situation in God's hands, because I truly cannot deal with all it alone.
Doctorpain
rohypnol.tblog.com/
Don't look for "Hillbilly heroin" here, Frank
posted by Linda on 28 Aug 2011 at 4:35 pmAs a participant in a clinical trial of extended-release tapentadol, I should warn anyone looking to "alter one's mental state" (as Frank so poetically puts it) that they'll have to look elsewhere. Tapentadol is a very effective chronic pain reliever, and although classified as an opioid, in my case the side effects - such as addiction, habituation, dependence, and any other physical or psychological effects - were essentially non-existent. Barring any medical conditions that would contraindicate its use and based upon my own positive experience, I would certainly recommend that anyone suffering with poorly controlled chronic pain ask their doctor about trying extended-release tapentadol.
A new variant of Hillbilly Heroin
posted by Frank on 27 Aug 2011 at 8:05 pmCOOL! A new variant of Hillbilly Heroin.
"Opioid medications, when crushed, have the potential for abuse". Although, I wonder why you should bother to crush it. Just swallow a lot of 'em. Let's face it folks, the desire to alter one's mental state is a wide-spread phenomenon. And when beer just isn't enough, it's time to go for something with more ooph.
Got to keep ahead of the Drug Warriors here...
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