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Medical Devices / Submissions and Approvals

European Commission Approves Opioid Dependence Implant

June 28, 2019
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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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