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The CHMP has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the EU as a substitution treatment for opioid dependence.
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the European Union as a substitution treatment for opioid dependence.
Sixmo is an implant that works through sustained-release of low levels of buprenorphine into the patient’s body over a period of six months. It has been indicated for use in clinically stable adult patients who require 8 mg or less of sublingual buprenorphine per day.
The implant comprises four small rods that are placed into a patient’s arm by a trained physician. Buprenorphine is continuously delivered via these rods over a six-month period and it is hoped that with this method of administration adherence can be improved and the risk of misuse or accidental overdose or ingestion can be reduced.
Three trials involving 626 patients have been performed to study the safety and efficacy of Sixmo, the results of which demonstrated that 96.4% of patients using Sixmo responded to treatment in comparison to 87.6% of patients treated with sublingual buprenorphine. An additional study is required in Europe to further evaluate the risks associated with the insertion and removal of the implant.
CHMP’s opinion represents an intermediary step to patient access. It’s recommendation will be sent to the European Commission, which will decide upon the adoption of an EU-wide marketing authorization.