Product Concept

POSIDUR™ 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
This investigational drug is currently in Phase III clinical studies in the U.S. and in Phase II clinical testing in Europe. Phase II results are not necessarily predictive of the results of Phase III trials. There have been numerous drug candidates that have succeeded in Phase II clinical trials that have later failed in Phase III clinical trials.

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