Shares Fall as the FDA Rejects Pacira's Application for Expanded Use of Pain Drug
Published: Mar 03, 2015
March 2, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
New Jersey-based biopharmaceutical company Pacira Pharmaceuticals, Inc. , announced today that the U.S. Food and Drug Administration (FDA) has sent a Complete Response Letter after reviewing the supplemental New Drug Application for its bupivacaine liposome injectable suspension, also known as Exparel. As a result, its shares have fallen more than 14 percent.
Exparel can be used in nerve block to provide postsurgical analgesia, or pain control. However, the FDA has rejected the sNDA from Pacira Pharmaceuticals, putting the product on hold. Pacira intends to schedule an End-of-Review meeting with the Division of Anesthesia, Analgesia and Addiction Products of the Center for Drug Evaluation and Research to gain insight into the CRL from the FDA.
“We are reviewing the contents of the CRL and will work actively with the FDA to bring this important new indication to our core and growing business in infiltration,” said Dave Stack, president, chief executive officer and chairman of Pacira. “Prescribed opioids in the acute care, postsurgical setting lead to chronic use and abuse in approximately one out of every 15 surgery patients in the United States; we remain committed to providing patients with long-acting, non-opioid analgesic options, like Exparel, to treat their pain while minimizing the risk of opioid-related adverse events. We look forward to finding solutions to address this public healthcare problem together with the FDA.”
A Closer Look at Exparel
Exparel is a local analgesic that uses bupivacaine with DepoFoam, delivery technology designed to provide patients with medication over a specific period of time. When it is used, it can provide a reduction in pain and opioid consumption, although reduced opioid levels have not shown any clinical benefits.
In August 2013, Pacira Pharmaceuticals released results from its Phase III clinical trial that looked at the safety and efficacy of Exparel. The drug did not meet its primary endpoint, which was to reduce cumulative pain scores over the course of 72 hours.
At the time, researchers stated that they were conducting further analysis to understand why some patients had positive results while others had a high placebo response. The trial included 180 people from countries including the U.S., Bulgaria, Poland and the Czech Republic. Some patients received 266mg of Exparel, while others received a placebo.
“While we will further examine the efficacy results for this trial, we are pleased with the initial assessment of safety in this model,” said Stack, at the time of the announcement.