EMA-mededeling: Nieuw, langdurig implantaat voor de behandeling van opioïdenverslaving

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.

Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months. It is indicated in clinically stable adult patients who require no more than 8 mg per day of sublingual (i.e. administered under the tongue) buprenorphine, within a framework of medical, social and psychological treatment.

The active substance of Sixmo is buprenorphine. It consists of four small rods that are implanted in the patient’s upper arm by a trained physician under local anaesthetic and continuously deliver buprenorphine for six months. This new method of administration could enhance adherence to the treatment and reduce the potential for misuse or accidental overdoses in the home, as well as the risk of accidental ingestion of buprenorphine by others, especially children.

The safety and efficacy of Sixmo were studied in three pivotal trials, in a total of 626 adult patients. One of the trials enrolled OUD adults who were considered clinically stable by their treating physician. The results demonstrated that 96.4% of patients in the Sixmo group responded to treatment, compared to 87.6% of patients treated with sublingual buprenorphine.

The applicant is required to perform an additional study in patients in Europe to further evaluate the risks associated with the insertion and removal of the implants.

The opinion adopted by the CHMP is an intermediary step on Sixmo’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once the marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.

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