Long-lasting opioid treatment recommended by an EMA committee
Marketing authorisation has been recommended in the EU by an EMA committee 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 8mg per day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Standard treatment of opioid use disorder (OUD) aims at reducing illicit opioid use, and usually involves long-term treatment with substitution opioid therapy, such as methadone or buprenorphine. 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 percent of patients in the Sixmo group responded to treatment, compared to 87.6 percent of patients treated with sublingual buprenorphine.
The most common adverse events associated with this medicine were headache, constipation and insomnia. These are normally associated with the active substance buprenorphine. The most common adverse reactions due to the insertion and removal techniques were pain, severe itching and haematoma at the implant site. In some patients implant breakages occurred.
The next stage is to perform an additional study in patients in Europe to further evaluate the risks associated with the insertion and removal of the implants.
The recommendation for marketing authorisation has been made by the European Medicines Agency’s human medicines committee (CHMP). 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.