POSIMIR is an investigational locally-acting nonopioid analgesic designed to provide 3 days of continuous pain relief after surgery. Administered just once at the close of surgery, POSIMIR is instilled directly into the surgical incision(s) with a blunt-tipped applicator or injected into targeted anatomic spaces under endoscopic guidance. Once placed, it forms a biodegradable depot that releases therapeutic levels of bupivacaine to the surgical site over 72 hours.
Based on DURECT’s proprietary SABER technology, POSIMIR was developed to play a central role in modern multimodal postoperative pain management protocols. It has been extensively studied in open, laparoscopic, and arthroscopic surgeries.
- 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
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 studies indicating that as many as 65% 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 (nausea, constipation, and sedation are most common) that delay mobilization, demand more intensive postoperative care, increase costs, and lower patient satisfaction. They are also subject to abuse, which has contributed to a serious national public health problem.
An extended-release, locally-acting, nonopioid analgesic such as POSIMIR, that covers the entire 72-hour postsurgical period during which pain control is most needed, could improve overall patient experience, lower costs, and lessen the reliance on opioids, filling an important medical need in both inpatient and outpatient surgical settings.
DURECT began enrolling patients in PERSIST, a Phase 3 clinical trial, in November 2015. More than 350 patients undergoing laparoscopic cholecystectomy (removal of the gallbladder) are expected to participate in the two sequential parts of the trial. In Part 1, patients were randomized on a 1:1 basis to receive POSIMIR or placebo as a one-time intra-incisional instillation at the close of surgery. In Part 2, patients are being randomized 1:1 to receive POSIMIR or the active control bupivacaine HCl.
In a previous trial of 50 patients using the same surgical model (laparoscopic cholecystectomy), POSIMIR demonstrated a reduction in pain intensity on movement of approximately 25% (P=0.024) over the first 3 days after surgery against the active control bupivacaine HCl, using the same statistical methodology specified for the PERSIST trial.
In 2 previous late-stage efficacy trials (hernia repair and shoulder arthroscopy), POSIMIR significantly reduced postoperative pain compared with placebo (by 31% and 21%, respectively) as well as postoperative opioid use (by 80% and 67%, respectively) over the first 72 hours after surgery.
The most common adverse reactions reported in clinical trials (occurring at a rate of at least 5% and more frequently than placebo) were: application site discoloration.
The PERSIST trial, in concert with other trials in the POSIMIR clinical program, is designed to support a robust NDA resubmission to the Complete Response Letter received in February 2014.
DURECT currently holds the worldwide rights to develop and commercialize POSIMIR.
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.