European approval for opioid dependence implant treatment

European approval for opioid dependence implant treatment
Credit: The US Food and Drug Administration

Titan Pharmaceuticals has secured European approval for Sixmo-buprenorphine, the brand name for Probuphine (buprenorphine) implant in the EU.

Sixmo is now approved for substitution treatment for opioid dependence in clinically stable adult patients.

“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,” said 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 commercialize Probuphine in other territories.”

In March 2018, Titan entered into a definitive asset purchase, supply and support agreement with Molteni.

“The registration of Sixmo marks our entry in the long-term buprenorphine market, strengthening our leadership in our core addiction market, as we strongly believe Sixmo represents a valuable option for a sizeable number of patients and physicians,” said Giuseppe Seghi Recli, MD of Molteni.