DURECT Completes Enrollment in PERSIST, Phase 3 trial for POSIMIR

DURECT Corporation announced that patient enrollment has been completed in PERSIST, the pivotal Phase 3 clinical trial of POSIMIR (SABER-Bupivacaine), an investigational locally acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery.

“The early completion of enrollment in PERSIST is an important milestone for our POSIMIR development program,” said James E. Brown, President and CEO of DURECT Corporation.  “We look forward to completing patient follow-up visits during the third quarter and announcing top-line data in the fourth quarter of this year.”

In May 2017, DURECT signed a development and commercialization agreement with Sandoz AG, a division of Novartis, covering the United States.  Under the terms of the agreement, Sandoz made an upfront payment to DURECT of $20 million following review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, with the potential for up to an additional $43 million in development and regulatory milestones, up to an additional $230 million in sales-based milestones, as well as a tiered double-digit royalty on product sales in the United States.  DURECT remains responsible for the completion of the ongoing PERSIST Phase 3 clinical trial for POSIMIR as well as FDA interactions through approval.