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Titan Therapeutics' opioid dependence implant Sixmo approved in Europe

Published on 27/06/19 at 11:32am
Image Credit: US Air Force Valerie Monroy

The European Commission has awarded marketing approval to Sixmo, a subdermal buprenorphine implant from Titan Therapeutics and Molteni, in all 28 European Member states for the substitution treatment of opioid dependence.

Specifically, the approval refers to adult patients who are clinically stable and require no more than 8mg per day of sublingual buprenorphine, “within a framework of medical, social and psychological treatment.

The product was previously approved by the FDA in 2016 under the name Probuphine. In 2018, Titan awarded Molteni the rights to the product in European and other regions.  

“This is a major milestone for us as well as for our commercialisation partner, Molteni, and we are looking forward to working with them to launch Sixmo in Europe,” commented Titan's President and CEO, Sunil Bhonsle. “The EU is the third major market in which Probuphine has been approved, and as the world's second largest market for buprenorphine-based products, we believe Sixmo could be a valuable treatment option for European healthcare providers and patients. In addition, we continue to consider opportunities to commercialise Probuphine in other territories.”

Giuseppe Seghi Recli, Managing Director at Molteni, added: “We look forward to progressively launching it across Europe, accomplishing one of the major milestones of our five-year European strategic plan of growth.”

Matt Fellows

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