Sixmo

On 19 June the European Commission withdrew the marketing authorisation for the implant Sixmo (buprenorphine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, L. Molteni \& C. dei Fratelli Alitti Societa di Esercizio S.p.A., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Sixmo was granted marketing authorisation in the EU on 20 June 2019 for substitution treatment for opioid dependence in clinically stable adults who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment. The marketing authorisation was initially valid for a 5\-year period. It was then granted unlimited validity in 2024\. Patients currently receiving treatment with Sixmo should have their implant removed at the end of the cycle and should be transitioned back to their previous sublingual buprenorphine dose to ensure continued treatment in accordance with the recommendations already included in the approved SmPC of the product. Several therapeutic alternatives are also available, as either buprenorphine alone or buprenorphine in combination with naloxone, in different pharmaceutical forms.