Titan announced the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application 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.
"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. We look forward to working with the EMA, and key stake-holders in Europe, throughout the regulatory review and approval process," said Kate Beebe, PhD, Titan's executive vice president and chief development officer.
Probuphine, a subdermal implant utilizingProNeura, is available in the U.S. as the only six-month treatment for opioid dependence that delivers buprenorphine continuously.
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. Upon issuance, this patent is expected to provide protection for Probuphine in Europe into 2023.