Orion Corporation announced today at the annual congress of the European Society of Intensive Care Medicine (ESICM) in Berlin that the company is launching its new intensive care sedative dexdor® (dexmedetomidine).
Orion received European centralised marketing authorisation for dexdor® in September and the product is already available in Germany, Austria, Denmark, Sweden, Finland, the UK and Ireland, and will be introduced in many other European countries during 2012.
Orion’s dexdor® is indicated for sedation of adult intensive care unit (ICU) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to a Richmond Agitation-Sedation Scale [RASS] 0 to -3).
Dexmedetomidine is the first new intensive care sedative introduced in Europe for over a decade. According to Mervyn Singer, Professor of Intensive Care Medicine at University College London, dexmedetomidine is a welcome innovation.
“Sedation in intensive care has been belatedly recognised as a big issue,” said Professor Singer.
“For years we complacently administered opiates, benzodiazepines and propofol, comfortable in our mistaken belief that these drugs were ‘non-toxic’ or, at least, a necessary evil.
“However, a plethora of recent studies suggest the opposite. Not only do these agents contribute to delayed weaning and an increased incidence of delirium, but their haemodynamic and immune suppressant effects may induce additional covert harm, such as a greater risk of nosocomial infection and an increased dependency on catecholamines to treat ‘shock’.
“These complications spill over into long-term neurocognitive and psychological problems, greater degrees of physical debilitation and delayed/truncated recovery.
“Thus, survival is achieved but at the cost of decreased survivorship, i.e. quality. The recent licensing of dexmedetomidine for use in European critical care provides a new option that merits further exploration to build on the vast experience in US and the new promising studies coming from the EU.
“It offers sedation albeit with ready rousability (increasing patient cooperativeness and communication), analgesia and a lack of respiratory depression, thus circumventing many of the downsides of our current armamentarium.
“While dexmedetomidine shouldn’t be viewed as a panacea, it does provide an important alternative means of sedation that could facilitate recovery of our patients.”
The marketing authorisation for dexdor® was based on the results of two clinical Phase III studies.
The results of the MIDEX and PRODEX studies conducted by Orion Corporation with dexmedetomidine indicate that dexmedetomidine met its first primary endpoint in providing similar sedation in intensive care compared to midazolam and propofol, the standard ICU sedative agents, in patients requiring light to moderate sedation for mechanical ventilation.
At the same time, dexmedetomidine showed additional advantages over standard sedatives. Safety findings were consistent with the known effects of dexmedetomidine and no significant new safety concerns were detected.
Dexmedetomidine is a sedative agent with selective alpha2-agonist activity originated by Orion’s pharmaceutical R&D. The product has been available with the brand name Precedex® in the USA since 2000 and Japan since 2004, where the distributor is Hospira under Orion’s license.