Durect (DRRX)

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DURECT Completes Enrollment in PERSIST, Phase 3 trial for POSIMIR®
PR Newswire
Thu June 22, 2017 7:00 AM


CUPERTINO, Calif., June 22, 2017 /PRNewswire/ -- DURECT Corporation (DRRX) today 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.

About PERSIST

PERSIST is a Phase 3 clinical trial consisting of patients undergoing cholecystectomy (gallbladder removal) surgery. Part 1 of PERSIST consists of 92 patients receiving either POSIMIR or placebo, and Part 2 consists of 296 patients receiving either POSIMIR or standard bupivacaine HCl. The primary efficacy endpoint for Part 2 is pain reduction on movement from 0-48 hours after surgery, with other key secondary endpoints including pain reduction on movement from 0-72 hours after surgery and 72-hour opioid use. In a previous clinical trial of 50 patients undergoing laparoscopic cholecystectomy, POSIMIR was compared with the active control bupivacaine HCl, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial. There can be no assurance that the PERSIST trial will show similar results, or provide sufficient data for FDA approval.

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. POSIMIR is a drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

About DURECT

DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR-928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury, chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver diseases with both broad and orphan populations, and inflammatory skin conditions such as psoriasis. DURECT's advanced oral, injectable, and transdermal delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology. For more information, please visit www.durect.com.