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