Suboxone viewed positively by EU regulators
US drugmaker Schering-Plough says that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing approval for use of its drug Suboxone (buprenorphine HCl /naloxone HCl sublingual tablets) in the treatment of opioid dependence. The Committee's view, which specifies that the product is used as part of a framework of medical, social and psychological therapy, is primarily based on data from a one-year clinical trial in opioid-dependent patients, which showed that individuals receiving the drug produced a significantly-higher proportion of opioid-free urine samples than those given placebo.
The firm added that the CHMP's positive opinion, if accepted by the EMEA, will serve as the basis for Suboxone's European-wide approval, with unified labeling valid in all 25 member states.
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