FDA Approves Tapentadol for Chronic Pain

Allison Gandey

August 26, 2011

August 26, 2011 (UPDATED September 13, 2011) — The US Food and Drug Administration (FDA) has approved tapentadol extended release (Nucynta, Janssen Pharmaceuticals) for moderate to severe chronic pain.

The drug, already approved for acute pain, has now been given the okay for long-term use, the company announced. In Europe, tapentadol is marketed as Palexia.

The drug is a centrally acting synthetic analgesic. The oral mu-opioid agonist is taken twice daily in adults when a continuous, around-the-clock analgesic is needed for an extended period. Tapentadol extended release is not intended for use on an as-needed basis.

As is recommended for other opioid analgesics, the dosing regimen of tapentadol should be individualized based on the severity of pain, previous experience with similar drugs, and the ability for follow-up and treatment monitoring. The recommended tapentadol extended-release total daily dose is 100 mg to 250 mg twice daily approximately every 12 hours, or 50 mg twice daily for patients not currently taking opioid analgesics, with a maximal daily dose not to exceed 500 mg. Patients taking immediate-release tapentadol may be converted to the extended-release formulation by administering half the total daily dose of tapentadol extended release approximately every 12 hours.

Tapentadol extended release is classified as schedule II of the Controlled Substances Act and carries risks for abuse similar to those of other opioids. Working with the FDA, Janssen has developed a risk evaluation and mitigation strategy for tapentadol.

The strategy, which is similar to those developed for other medications in this category, is designed to educate prescribers about the potential for abuse, addiction, and overdose.

Janssen says it also plans to monitor for inappropriate use of its products.

Chronic pain is the most common cause of long-term disability; almost one third of Americans will reportedly experience chronic pain at some point in their lives.

Despite the treatments available, the American Pain Society says additional options are still needed to help patients manage their pain.

"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," said Sunil Panchal, MD, president of the National Institute of Pain, in a news release. "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."

Tapentadol extended release was studied in 4 trials in patients with moderate to severe chronic pain. Efficacy was demonstrated in 1 randomized, double-blind, placebo-controlled, and active-controlled study in patients with chronic low back pain, and in 1 randomized, double-blind, placebo-controlled study in patients with pain related to diabetic peripheral neuropathy.

The most common adverse reactions, appearing in at least 10% of patients, were nausea, constipation, headache, dizziness, and somnolence.

Life-Threatening Serotonin Syndrome

Respiratory depression is the primary risk for mu-opioid agonists. They can also raise cerebrospinal fluid pressure and should not be used in patients who may be susceptible to the effects, such as those with evidence of head injury and increased intracranial pressure.

Tapentadol extended release has not been evaluated in patients with a predisposition to a seizure disorder.

The product is also contraindicated in patients who are receiving monoamine oxidase inhibitors or who have taken them within the last 14 days because of potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.

Cases of life-threatening serotonin syndrome have been reported with the concurrent use of tapentadol and serotonergic drugs. This includes serotonin reuptake inhibitors; serotonin and norepinephrine reuptake inhibitors; tricyclic antidepressants; triptans; drugs that affect the serotonergic neurotransmitter system, such as mirtazapine, trazodone, and tramadol; and drugs that impair metabolism of serotonin.

Tapentadol should not be used during and immediately before labor and delivery, and neonates whose mothers have been taking tapentadol should be monitored for respiratory depression. Mothers taking tapentadol should not breast-feed. In patients younger than 18 years, the safety and effectiveness of tapentadol have not been determined. For elderly patients, an initial dose should be carefully selected. Although tapentadol may be used with caution in patients with moderate hepatic impairment, it is not recommended for use in patients with severe renal or hepatic impairment.

Complete product information is available on the FDA Web site.

Laurie Barclay, MD, contributed to the news brief.

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