EMA Panel Backs Long-Lasting Implant for Opioid Dependence

Megan Brooks

April 26, 2019

A European Medicines Agency (EMA) advisory panel has recommended approval of a buprenorphine implant (Sixmo, L. Molteni & C. dei Fratelli Alitti Società di Esercizio SpA) as a substitution treatment for opioid dependence.

Sixmo consists of four small rods implanted in the upper arm under local anesthetic. It continuously delivers low levels of buprenorphine for 6 months and is appropriate for clinically stable adults who require no more than 8 mg daily of sublingual buprenorphine, within a framework of medical, social and psychological treatment, the EMA said in a statement.

"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 EMA said.

The safety and efficacy of the implant were demonstrated in trials involving a total of 626 adults. The most common adverse events associated with the implant were headache, constipation, and insomnia, which are typical of buprenorphine treatment.

The most common adverse reactions due to implant insertion and removal were pain, severe itching, and hematoma at the implant site. In some patients, implant breakages occurred. The company is required perform an additional study in patients in Europe to further evaluate the risks associated with the insertion and removal of the implants.

Research has shown that buprenorphine implants work as well if not better than sublingual buprenorphine as maintenance treatment of opioid dependence. 

The US Food and Drug Administration (FDA) approved the first buprenorphine implant (Probuphine, Titan Pharmaceuticals/Braeburn Pharmaceuticals) in 2016. 

The positive opinion on Sixmo by the EMA's Committee for Medicinal Products for Human Use will be sent to the European Commission for a final decision on marketing.

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