CHMP recommends Sixmo to treat opioid dependence

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.

The applicant - Molteni Farmaceutici- 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 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.