New Drug Choice for Treating Acute Pain

A new immediate-release oral tablet offers patients and healthcare professionals an additional choice for the central nervous system (CNS) treatment and relief of moderate to severe pain.

The new drug, tapentadol hydrochloride, is a centrally acting oral analgesic that acts as both an opioid and nonopioid agent. It acts primarily as a mu-opioid-receptor agonist by modifying the sensory and affective aspects of pain, inhibiting the transmission of pain at the spinal cord, and affecting activity at parts of the brain that control how pain is perceived. Tapentadol also inhibits reuptake and reabsorption of norepinephrine into nerve cells, thus increasing the level of norepinephrine in the brain, which may also have an analgesic effect.

Tapentadol 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. The most common side effects from Tapentadol are nausea, dizziness, vomiting, and sleepiness, and the labeling also includes warnings about the risk of respiratory depression; addictive depressive effects on the CNS when taken with alcohol, other opioids, or illicit drugs; and abuse potential. Tapentadol tablets have been approved in 50 mg, 75 mg, and 100 mg doses. Tapentadol is manufactured by Johnson & Johnson (New Brunswick, NJ, USA), and has been approved by the US Food and Drug Administration (FDA).

"This approval offers healthcare professionals an additional choice for treating moderate to severe pain," said John Jenkins, M.D., director of the office of new drugs at the FDA Center for Drug Evaluation and Research (CDER; Atlanta, GA, USA). "Opioids are considered safe and effective in selected patients but can cause dependence, abuse, and addiction. Patients treated with opioids require careful monitoring by their healthcare professional for signs of abuse."

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Johnson & Johnson
FDA Center for Drug Evaluation and Research