Product Concept

POSIDUR™ (SABER® - Bupivacaine) is a long-acting local anesthetic being developed for the treatment of post-surgical pain. It is administered during surgery to the surgical site, where it continuously releases therapeutic levels of bupivacaine in a controlled fashion, providing up to 72 hours of uninterrupted local analgesia.

According to data published by the Center for Disease Control and Prevention, there are approximately 72 million ambulatory and inpatient procedures performed in the United States. Epidemiological studies indicate that up to 100% of surgical patients experience postoperative pain, with 50-75% reporting inadequate pain relief. The current standard of care for post-surgical pain includes oral opiate and non-opiate analgesics, transdermal opiate patches and muscle relaxants. While oral analgesics can effectively control post-surgical pain, they commonly cause side effects such as drowsiness, constipation, cognitive impairment and other possible side effects. Effective pain management can be compromised if patients fail to adhere to recommended dosing regimens because they are sleeping or disoriented. Post-surgical pain can be treated effectively with local anesthetics; however, the usefulness of current conventional medications is limited by their short duration of action.

Potential Product Benefits:

	Reduction in use of narcotics for post operative pain, which should in turn reduce opioid-related side effects such as nausea, vomiting, GI upset, cognitive impairment, etc.
	Improve post-operative analgesia in a wide variety of procedures.
	Reduce post-operative recovery time.
	Potential to reduce the duration of hospital stays and may allow some inpatient procedures to become outpatient procedures.
	Reduce the amount of time surgeons, nurses and other hospital staff spend managing post-surgical pain.

Current Clinical Status
A total of 15 clinical trials in subjects undergoing various surgical procedures have been conducted with POSIDUR. In all, 1,060 subjects have been studied in the POSIDUR Phase 2 and 3 clinical development program, of which 668 have been treated with POSIDUR, 268 with SABER-Placebo (SABER vehicle without drug), and 124 with bupivacaine HCl solution. In July 2012, we completed pre-NDA communications with the FDA regarding POSIDUR. Through this process, we have received guidance and thoughtful comments from the FDA covering various chemistry, manufacturing, nonclinical, clinical pharmacology, clinical, statistical and product labeling topics based on our pre-NDA meeting questions. In April 2013, we submitted a new drug application as a 505(b)(2) application, which relies in part on the FDA’s findings of safety and effectiveness of a reference drug. We expect that the FDA will notify us whether our NDA submission has been accepted for filing in June 2013. If accepted for filing, the FDA would be expected to assign a Prescription Drug User Fee Act (PDUFA) target date (the date the FDA expects to complete its review of the POSIDUR NDA) in the first quarter of 2014. There can be no assurance that such an NDA submission will be accepted for review by the FDA or that marketing approval will occur by the FDA or other regulatory agencies. The FDA may require additional clinical trials or additional data before accepting the NDA or granting marketing approval.

To review data on POSIDUR reported at the 2008 American Hernia Society meeting, click here.