European Commission has approved Sixmo for treatment of opioid dependence

Titan Pharmaceuticals, Inc. has announced that the European Commission ("EC") has approved Sixmo-buprenorphine, the brand name for Probuphine (buprenorphine) implant in the European Union ("EU"). The EC's decision, received by Molteni, applies to all 28 EU member states, where Sixmo is now approved for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.

Comment: In March 2018, Titan entered into a definitive asset purchase, supply and support agreement with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. ("Molteni") through which Molteni acquired the European intellectual property related to Probuphine, including the MAA under review by the EMA, and gained the exclusive right to commercialize the Titan supplied Probuphine product in Europe, as well as certain countries of the Commonwealth of Independent States, the Middle East and North Africa.

Comment: The subdermal implant, which delivers buprenorphine at a continuous rate for six months following insertion, received FDA approval in 2016 under the name Probuphine.