The European Medicines Agency has accepted for review Titan Pharmaceuticals’ (NASDAQ:TTNP) marketing authorization application (MAA) for Probuphine.
The acceptance marks the beginning of the EMA's regulatory review process for Probuphine for substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Probuphine, a subdermal implant utilizing Titan’s ProNeura drug delivery technology, is available in the U.S. as the only six-month treatment for opioid dependence that delivers buprenorphine continuously.
"The acceptance of the MAA for Probuphine is an important step toward bringing Probuphine to a wide population of patients suffering from opioid use disorder in Europe, the second largest market for buprenorphine-based products worldwide,” Kate Beebe, Titan's EVP and chief development officer, said in a statement.
In October 2017, Titan received a notice of allowance from the European Patent Office for a patent covering methods of use claims for treating opioid dependence with a subdermal implant containing buprenorphine. The patent is expected to provide protection for Probuphine in Europe into 2023.