November 21 the company Johnson & Johnson reported the approval of the Office of the Food and Drug Administration USA (Food and Drug Administration - FDA) of its new painkiller tapentadola for use in moderate and significantly expressed pain syndrome in patients older than 18 years at a dose of 50, 75 and 100 mg. Tapentadol is an innovative oral analgesic action dib of the central type, combining agonism μ-opioid receptors and inhibition of norepinephrine dib reuptake.
Drug approval was based on data from clinical trials involving more than two thousand patients, according to which tapentadol was more effective in moderate to severe pain compared with placebo. The results of these studies were presented at the 27th Annual Scientific Meeting of the American Pain Society (American Pain Society) at the beginning of this year.
Following the approval of the FDA drug status tapentadola will be considered by the Office for Drug Control USA (US Drug Enforcement Agency), and the drug will not be placed on the market until until assigned to a classification group.
Joanna Valdstreycher (Joanne Waldstreicher), MD, global head of research and development of products Johnson dib & Johnson , noted that tapentadol dib is a new word in the treatment dib of pain and that the company is pleased to provide patients with a brand new painkiller.
In the U.S., the company was marketed tapentadol will PriCara - division Ortho-McNeil-Janssen Pharmaceuticals, Inc. (Which is a subsidiary company Johnson & Johnson ).
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