POSIMIR®(bupivacaine extended-release solution)
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 is currently in Phase 3 clinical development and has not been approved by the FDA for marketing in the U.S. for any indication.
On June 27, 2019, DURECT announced the submission of a full response to the Complete Response Letter (CRL) it previously received from U.S. Food and Drug Administration (FDA) related to POSIMIR® (bupivacaine extended-release solution). The submission is intended to address the issues raised in the CRL and seeks FDA approval of POSIMIR based on what the Company and its advisors believe is adequate evidence of both safety and efficacy.
DURECT commissioned the advisory services of Dr. Lee S. Simon to first evaluate the adequacy of the existing POSIMIR package to address the issues raised in FDA correspondence, including the CRL, and then to lead the Company’s efforts to submit its response to the CRL. Dr. Simon is a physician and research scientist who served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products from 2001 to 2003, and is now a Principal at SDG, LLC, an FDA advisory firm. As the submission is intended to be a full response to the CRL, as opposed to a new NDA submission, the Company expects a 6-month FDA review period.
DURECT holds worldwide commercialization rights to 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.