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FDA Approves Tapentadol for Relief of Moderate to Severe Acute Pain

tapentadol hydrochloride, a centrally acting analgesic, for relief of moderate to severe acute pain. The drug was reported to have fewer adverse effects than existing pain therapies such as opioids. Tapentadol has two mechanisms of action, combining mu-opioid receptor agonism and also inhibition of the reuptake of norepinephrine. Mu-opioid agonists bind to and activate mu-opioid receptors in the CNS, modifying sensory and affective aspects of pain; norepinephrine reuptake inhibitors increase the level of noradrenaline in the brain by inhibiting its absorption into nerve cells. The FDA based its approval on data from several phase 3 studies reported at the American Pain Society annual meeting last May. In three separate trials involving a total of 2,100 patients, investigators reported significant pain relief compared with placebo for foot surgery; end-stage joint disease; and low backache or osteoarthritis of the hip and knees.