Durect announced that Indivior has reported that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Perseris (risperidone), which was formerly known as RBP-7000. As described by Indivior, Perseris is the first once-monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults.
"We are pleased to see PERSERIS receive FDA approval as an innovative treatment option for patients suffering from the very difficult medical condition of schizophrenia," said Jim Brown, President and CEO of Durect.
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On September 26, 2017, Durect entered into a patent purchase agreement whereby Durect has assigned to Indivior UK Limited, an affiliate of Indivior, certain patents that may provide further intellectual property protection for Perseris. In consideration for such assignment, Indivior made an upfront non-refundable payment to Durect of $12.5 million. Indivior also agreed to make an additional $5 million payment to Durect contingent upon NDA approval of Perseris, 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 Perseris. The patent rights include granted patents extending through at least 2026.