Sipaco's Orlaam Approved By EMEA
The European Medicines Evaluation Agency has approved SipacoInternacional of Portugal's application to market Orlaam (levacetylmethadol) for the maintenance treatment of opiate addiction in adults previously treated with methadone.
Orlaam is structurally related to methadone and has similar pharmacological activity. However, it has the advantage of being able to be given three times a week, rather than once a day. The long-term drop-out rate is similar with both drugs. However, Orlaam has been associated with some cardiovascular disturbances (QT interval prolongation), and a condition for approval is that further comparative studies with methadone should be conducted.
Orlaam was approved in 1993 in the USA, where the license holder is Biodevelopment Corp. It is marketed in the USA by Roxane Laboratories.
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