FDA Approves Tapentadol for Moderate to Severe Acute Pain

Susan Jeffrey

November 25, 2008

November 25, 2008 — The US Food and Drug Administration (FDA) has announced approval of tapentadol hydrochloride (Johnson & Johnson), an immediate-release oral tablet for the relief of moderate to severe acute pain.

The drug, for which a trade name has not yet been established, is a centrally acting analgesic that will be available in doses of 50, 75, and 100 mg.

"This approval offers healthcare professionals an additional choice for treating moderate to severe pain," John Jenkins, MD, director of the office of new drugs at the FDA's Center for Drug Evaluation and Research, said in a statement from the FDA.

The drug acts as both an opioid and nonopioid agent, the FDA release notes. It acts primarily as a mu-opioid-receptor agonist but also inhibits reuptake of norepinephrine, which may also have an analgesic effect.

A statement from Johnson & Johnson notes that following this FDA approval, "as per federal regulation for all controlled substances, tapentadol will be reviewed by the US Drug Enforcement Administration for scheduling, and it cannot be sold until it receives a scheduling classification."

"Opioids are considered safe and effective in selected patients but can cause dependence, abuse, and addiction," the FDA release adds. "All patients treated with opioids require careful monitoring by their healthcare professional for signs of abuse."

The approval was based on data from clinical studies involving more than 2100 patients, the Johnson & Johnson release notes. These phase 3 studies, presented at the 27th Annual Scientific Meeting of the American Pain Society in May, showed significant relief compared with placebo for patients undergoing bunionectomy, a common foot surgery; in pain from end-stage joint disease; and with low back pain or osteoarthritis of the hip or knee. It was generally well tolerated.

The most common adverse effects from tapentadol are nausea, dizziness, vomiting, sleepiness, and headaches, the FDA release said. "The labeling for tapentadol includes warnings about the risk of respiratory depression; addictive depressive effects on the central nervous system when taken with alcohol, other opioids, or illicit drugs; and abuse potential," the FDA release adds.

In its statement, the company also notes that the new drug is contraindicated in any situation where mu-opioids are contraindicated, such as in significant respiratory depression, acute or severe bronchial asthma, or hypercapnia; in patients with paralytic ileus; or in those who are currently using or are within 14 days of using monoamine oxidase inhibitors (MAOIs). The drug should be prescribed "with care" in patients with a history of a seizure disorder or any condition that would put the patient at risk for seizures.

Finally, the Johnson & Johnson release points out that a potentially life-threatening serotonin syndrome may occur with tapentadol, "particularly with concomitant use of serotonergic drugs such as [selective serotonin-reuptake inhibitors] SSRIs, [serotonin-norepinephrine-reuptake inhibitors] SNRIs, [tricyclic antidepressants] TCAs, MAOIs, and triptans and with drugs that impair metabolism of serotonin (including MAOIs)."

Tapentadol is manufactured by Johnson & Johnson. PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, will market tapentadol in the United States. Both are wholly owned subsidiaries of Johnson & Johnson, the company release notes.

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