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FDA Approves New Drug to Alleviate Moderate to Severe Pain

Posted Dec 01 2008 10:08am

The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain.

Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.

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

Tapentadol acts in two ways, opioid (narcotic) and non-opioid. It affects the brain and body primarily by activating opioid receptors in the brain, spinal cord and gastrointestinal tract. In addition, Tapentadol inhibits the reuptake of the brain chemical norepinephrine which possibly has an analgesic effect.

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