The European Medicines Agency announced April 26 that its human medicines committee has recommended granting a marketing authorization for Sixmo, a long-lasting implant delivering buprenorphine as treatment for opioid use disorder (OUD).
This recommendation is a step toward making the product available to patients with OUD in the European Union, according to afrom the EMA. Safety and efficacy of the implant were studied in three trials with a total of 628 patients.
Standard treatment of OUD includes psychological and social counseling, as well as substitution opioid therapy – such as methadone or buprenorphine. The Sixmo implant involves four small rods implanted in the patient’s upper arm under local anesthetic.
The most common adverse events associated with the medicine were in keeping with the known events associated with buprenorphine – headache, constipation, and insomnia. Insertion and removal were associated with pain, severe itching, and hematoma at the implant site.
Thecan be found on the EMA website.