POSIMIR®(bupivacaine extended-release solution)

Overview

POSIMIR is an investigational nonopioid analgesic being evaluated for its ability to provide 3 days of continuous local pain relief after surgery. Intended for administration just once at the close of surgery, POSIMIR may be instilled directly into the surgical incision(s) with a blunt-tipped applicator or injected into targeted anatomic spaces under endoscopic guidance. Once placed, clinical and nonclinical studies have shown it to form a biodegradable depot that releases bupivacaine directly to the surgical site at a stable rate for 72 hours.

Based on DURECT's proprietary SABER® technology, POSIMIR is anticipated to play a central role in modern multimodal postoperative pain management protocols. It has been studied in open, laparoscopic, and arthroscopic surgeries. It has not been approved by the FDA for marketing in the U.S. for any indication.

POSIMIR is being studied for its ability to:

  • Improve postoperative pain control in a wide variety of surgical procedures
  • Reduce the use of postoperative opioids and their attendant side effects
  • Improve postsurgical mobilization and enhance recovery
  • Reduce the duration and cost of hospital stays
  • Reduce the resources required to manage postoperative pain and opioid-related side effects

POSIMIR is an investigational new drug and has not been approved by the FDA for marketing in the U.S. for any indication.

Approximately 72 million surgical procedures are performed annually in the United States. Despite improvements in anesthetic and analgesic techniques, insufficient postoperative pain control remains a significant problem, with a recent study indicating that as many as two-thirds of surgical patients experience moderate-to-extreme pain after surgery.

Opioid pain relievers, though widely used postoperatively, have important limitations. They cause undesirable side effects (most commonly nausea, constipation, and sedation) that can delay mobilization, demand more intensive postoperative care, and lower patient satisfaction. They also pose risks of abuse, misuse, and addiction that have contributed to a serious national public health emergency.

POSIMIR is a nonopioid, locally-acting analgesic whose ability to reduce postoperative pain and lower opioid analgesic use is currently under evaluation. If approved by the FDA, it could fill an important medical need in both the inpatient and outpatient surgical settings.

POSIMIR has not been approved by the FDA for marketing in the U.S. for any indication.

After a comprehensive review of the POSIMIR program in light of the issues raised by the FDA in DURECT's communications with them, including the Complete Response Letter (CRL), DURECT prepared and submitted a response to the CRL in June 2019. The FDA agreed to file the submitted response as a complete Class 2 Resubmission and initially assigned a user fee goal date of December 27, 2019. The FDA subsequently scheduled an Advisory Committee meeting for January 16, 2020; a new user fee goal date has not been assigned. At the meeting, six Advisory Committee members voted to recommend that the efficacy, safety, and overall risk-benefit profile of POSIMIR support approval, while six did not support approval based on the information presented. Although the FDA considers the recommendations of the Advisory Committee, the recommendations by the panel are non-binding. The final decision regarding pending regulatory actions for a product is made by the FDA.

The effort to evaluate the program, develop a strategy for filing the response, and preparing the response has been under the direction of Dr. Lee Simon, who was formerly FDA’s Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products. Dr. Simon also led our preparation efforts for the Advisory Committee meeting.

DURECT holds worldwide commercialization rights to POSIMIR.

Learn more about SABER technology

There are risks and uncertainties associated with our business. Please see our most recent SEC filings (10-K or 10-Q) for a complete description of these risks and uncertainties, which are incorporated herein by reference.