FDA grants OK to new oral analgesic

Rockville, Md.—The Food and Drug Administration has given marketing approval for a new drug that gives health care providers an additional choice for treating pain.

Tapentadol hydrochloride is an immediate-release oral tablet for the relief of moderate to severe acute pain. The drug is a centrally-acting synthetic analgesic and is available in doses of 50, 75 and 100 milligrams.

The drug, which is manufactured by Johnson & Johnson Pharmaceutical Research & Development LLC, does not yet have a trade name.

Tapentadol is a novel analgesic that acts in two ways, as an opioid and non-opioid, and affects the brain and body primarily by activating mu-opioid receptors in the brain and spinal cord. Its non-opioid action is through the inhibition of norepinephrine re-uptake in the brain.

The most common side effects from Tapentadol are nausea, dizziness, vomiting and sleepiness—similar to other opioid analgesics—and the labeling for Tapentadol includes warnings about the risk of respiratory depression; additive depressive effects on the central nervous system when taken with alcohol, other opioids or illicit drugs; and abuse potential.