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news.Schering-Plough has reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of sugammadex for routine reversal of the muscle relaxants rocuronium or vecuronium and for immediate reversal of rocuronium in adults, and for routine reversal following rocuronium in children and adolescents.
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The Committee for Medicinal Products for Human Use (CHMP) positive opinion is based on a comprehensive clinical trial program including the results from the Signal and Aurora clinical trials. Signal clinical findings demonstrate that the median times to reversal of muscle relaxation to a train-of-four (TOF) ratio of 0.9 occurred in 2.7 minutes in the sugammadex group and 49 minutes in the neostigmine or glycopyrrolate group.
Aurora clinical findings demonstrate that the median times to reversal of muscle relaxation to a TOF ratio of 0.9 occurred in 1.4 minutes in the sugammadex group, and in 17.6 minutes in the neostigmine/glycopyrrolate group.
The CHMP recommendation serves as the basis for a European Commission approval of this novel medicine. Upon European approval, sugammadex will be the first and only selective relaxant binding agent and will enable anesthesiologists to rapidly and predictably reverse both moderate and deep muscle relaxation induced by rocuronium and vecuronium.
According to the company, sugammadex creates the opportunity for anesthesiologists to maintain optimal muscle relaxation to the end of a surgical procedure and to reverse the block in minutes.
Thomas Koestler, executive vice president and president, Schering-Plough Research Institute, said: “This product has the potential to modernize the use of anesthesia around the world.”