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EMA Recommends Buprenorphine Implant Device

May 1, 2019
Trial shows better patient response to Sixmo than sublingual buprenorphine

A PPM Brief

The European Medicine Agency (EMA), through its Committee for Medicinal Products for Human Use (CHMP), has recommended1 marketing authorization in the EU for Sixmo (buprenorphine) as a treatment for opioid use disorder (OUD). Sixmo is an implantable device of four small rods in the patient’s upper arm that releases low levels of buprenorphine over a 6-month period. The device is indicated for adult patients who require no more than 8 mg per day of sublingual buprenorphine.

(Source: 123RF)

Three clinical trials (n = 626) supported Sixmo’s safety and efficacy. In one such trial targeting individuals with OUD, 96.4% of patients in the Sixmo group responded to treatment compared to 87.6% of patients treated with sublingual buprenorphine. This method of administering buprenorphine treatment could enhance adherence and reduce the potential for misuse, accidental ingestion, and/or overdoses, according to an EMA press release.

The most common adverse events reported with Sixmo were headache, constipation, and insomnia; these same side effects are typically associated with buprenorphine. The most common adverse reactions due to implant insertion and removal were pain, severe itching, and hematoma at the implant site, and, in some patients, implant breakages occurred. The agency also noted that, in order to use Sixmo, physicians must be competent in minor surgery and have received prior training on the implant’s insertion and removal.

Last updated on: June 14, 2019
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