The FDA has approved tapentadol hydrochloride, an immediate-release oral tablet in doses of 50, 75, or 100 mg for the relief of moderate-to-severe acute pain.

Tapentadol is a centrally-acting synthetic analgesic that affects the brain and body largely by activating opioid receptors in the brain, spinal cord, and GI tract. It also inhibits the reuptake of norepinephrine, which may have an analgesic effect.

“This approval offers health-care professionals an additional choice for treating moderate-to-severe acute pain,” said John Jenkins, MD, director of the office of new drugs in the FDA’s Center for Drug Evaluation and Research.

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Tapentadol is manufactured by Janssen Ortho, LLC, Gurabo, P.R.