European Commission approves Titan Pharmaceuticals, Molteni's Sixmo implant for opioid dependence

Titan Pharmaceuticals on Wednesday announced that the European Commission approved the subdermal implant Sixmo (buprenorphine) for substitution treatment for opioid dependence in clinically stable adults who require a sublingual buprenorphine dose of no more than 8 mg per day. CEO Sunil Bhonsle said "this is a major milestone for us," adding "the EU is the third major market in which [the treatment] has been approved, and as the world's second largest market for buprenorphine-based products."

In 2016, the subdermal implant gained US approval under the name Probuphine for the treatment of opioid dependence, where it is jointly marketed with Braeburn Pharmaceuticals under the terms of a 2012 partnership. Meanwhile, last year, Titan granted Molteni rights to the therapy in Europe and other select regions, with the deal later amended to include a provision linked to European approval of the drug.

Molteni managing director Giuseppe Seghi Recli remarked "we look forward to progressively launching it across Europe, accomplishing one of the major milestones of our five-year European strategic plan of growth." Sixmo was developed using Titan's ProNeura continuous drug delivery system and is designed to deliver buprenorphine continuously for six months following insertion.

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