The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a substitution treatment for opioid dependency in clinically-stable adult patients who require no more than 8 mg/day of sublingual buprenorphine.
Sixmo consists of four small rods that are implanted in the patient’s upper arm under local anaesthetic and continuously deliver buprenorphine for six months. The EMA says the therapy could enhance treatment adherence and reduce the potential for misuse or accidental overdoses.
The safety and efficacy of Sixmo were studied in three pivotal trials, comprising a total of 626 participants, which showed that in clinically-stable patients with opioid use disorder, the treatment achieved a response rate of 96.4 per cent compared to 87.6 per cent of patients treated with sublingual buprenorphine.
The most common adverse events were headache, constipation, and insomnia. The most common adverse reactions at the implant site were pain, severe itching and haematoma. In some patients, implant breakages occurred.
The EMA 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 national level.