Grey Approved Stamp

European Commission Approves Opioid Dependence Implant

June 27, 2019

Titan Pharmaceuticals and Molteni’s Sixmo (buprenorphine) subdermal implant for treating opioid addiction has earned European regulatory approval.

The device is now cleared in all European member states as a substitute treatment for clinically stable adults who require no more than eight milligrams of sublingual buprenorphine a day.

The subdermal implant, which delivers buprenorphine at a continuous rate for six months following insertion, received FDA approval in 2016 under the name Probuphine.

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