Durect announces NDA acceptance of Indivior's RBP-7000 risperidone monthly depot
Durect announced that Indivior PLC has reported that the FDA has accepted the New Drug Application for RBP-7000. RBP-7000 is an investigational, once-monthly injectable risperidone for the treatment of schizophrenia. Indivior PLC further reported that the FDA has set a Prescription Drug User Fee Act target action date of July 28, 2018. On September 26, Durect entered into a patent purchase agreement whereby Durect has assigned to Indivior UK Limited, an affiliate of Invidior PLC, certain patents that may provide further intellectual property protection for RBP-7000. Indivior has made an upfront non-refundable payment to Durect of $12.5M and has also agreed to make an additional $5M payment to Durect contingent upon NDA approval of RBP-7000, as well as quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the assigned patent rights, including RBP-7000. The patent rights include granted patents extending through at least 2026.