DURECT Corporation (NASDAQ:DRRX) has reached a milestone - enrolling all patients in a pivotal phase III trial of its opioid analgesic POSIMIR.
POSIMIR aims to provide three days of continuous pain relief after someone has undergone surgery.
"The early completion of enrollment in PERSIST is an important milestone for our POSIMIR development program," James E. Brown, the president and chief executive of DURECT Corporation said.
"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."
Significantly, last month, DURECT signed a development and commercialization agreement with Sandoz AG, a division of Novartis, covering the United States.
Sandoz has made an upfront payment to DURECT of $20mln, 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.
PERSIST is the name given to the trial, which consists of patients undergoing cholecystectomy (gallbladder removal) surgery.
POSIMIR is a drug candidate under development and has not yet been approved for commercialization by the US Food and Drug Administration (FDA) or other health authorities.