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-Bupivacaine), did not meet its primary efficacy endpoint of reduction in pain on movement over the first 48 hours after surgery as compared to standard bupivacaine HCl.
While results trended in favor of POSIMIR versus the comparator, they did not achieve statistical significance.
POSIMIR is an investigational drug candidate being developed for the treatment of post-surgical pain. "We appreciate the efforts of the investigators and patients who participated in PERSIST, and we thank Sandoz for their support." About POSIMIR (SABER-Bupivacaine) POSIMIR is an investigational extended-release depot utilizing DURECT's patented SABER technology intended to continuously deliver bupivacaine to the surgical site for 72 hours to provide up to three days of continuous pain relief after surgery.
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Sandoz will pay the Company a tiered double-digit royalty on product sales for a defined period, after which the license granted to Sandoz shall convert to a non-exclusive, fully paid, royalty-free, irrevocable and perpetual license.One late-stage product candidate in this category is POSIMIRtechnology.In addition, for the assignment of certain patent rights, DURECT may receive a milestone payment from development and single digit sales based earn-out payments from sale of Indivior's RBP-7000 investigational drug for schizophrenia, for which Indivior recently submitted an NDA. NOTE: POSIMIR are trademarks of DURECT Corporation.DURECT is responsible for the completion of the ongoing PERSIST Phase 3 clinical trial for POSIMIR as well as FDA interactions through approval.DURECT also has certain manufacturing obligations under this agreement.
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