FDA approves new drug for moderate to severe pain

The U.S. FDA has approved tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain in adults ages 18 years and older, according to an agency press release.

Tapentadol is a centrally acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg. It is both an opioid and nonopioid, activating the opioid receptors in the brain, spinal cord, and gastrointestinal tract and also inhibiting the reuptake of norepinephrine in the brain.

The most common side effects from tapentadol are nausea, dizziness, vomiting, and sleepiness. 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.

Tapentadol will be marketed in the U.S. by Johnson & Johnson; a brand name has not yet been determined. Before tapentadol is available for use, however, it must be reviewed by the U.S. Drug Enforcement Agency to determine its classification as a controlled substance.

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