Pacira Pharmaceuticals, Inc. (PCRX)

[DADDY FAT SAXX]

while we wait a recap

Federal regulators are set to rule today whether an extended-release version of a government-approval local anesthetic can be sold by Pacira Pharmaceuticals, which has its main operations in La Jolla.

Exparel, a post-surgical injection administered at the surgical site, is designed to delay and shorten the need for pain relief from opioids such as morphine, which can cause costly and potentially life-threatening side effects, according to the company and its researchers.

The drug combines the anesthetic bupivacaine, which is sold by AstraZeneca, and DepoFoam, a fatty product developed by Pacira for holding medicine inside microscopic chambers for extended release.

If approved, Exparel could generate peak annual sales of $362 million in the United States and $576 million worldwide, according to reported estimates by the Los Angeles investment firm Wedbush Securities.

The Food and Drug Administration originally was scheduled to decide on Pacira's new drug application for Exparel by July 28, but the agency postponed the deadline three months after requesting additional information about the drug from its maker.

A new analysis of data from five clinical trials of Exparel showed that patients receiving the drug went without an opioid 3-1/2 times longer than those who received bupivacaine alone (9.9 hours versus 2.7 hours).

The Exparel patients also received 50 percent less opioids than the others, and they reported less pain over 72 hours.

While Pacira is headquartered in Parsippany, N.J., most of its employees work at its manufacturing and research and development center near the University of California San Diego campus.


Good luck to those who chose to hold through this bad boy.