Pacira Pharma Receives FDA Warning Letter Regarding Exparel

(RTTNews) - Pacira Pharmaceuticals Inc. (PCRX) said Thursday that it has received a warning letter from the U.S. Food and Drug Administration or FDA, referencing certain promotional materials related to the company's flagship drug, Exparel, a time-release pain medication.

Exparel is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia in adult patients 18 years of age or older. It was approved by FDA in October 2011 and launched in the U.S. in April 2012.

Parsippany, New Jersey-based Pacira Pharma has also sought FDA approval for the expanded use of Exparel in a nerve block indication. The regulatory agency's decision is expected by March 5, 2015.

The FDA's Office of Prescription Drug Promotion, or OPDP, said in its warning letter it has evidence that Exparel is intended for new uses for which it does not have approval, and for which its labeling does not provide adequate directions for use, thus rendering Exparel "misbranded".

The FDA noted that Pacira Pharma's claims suggested that Exparel is safe and effective for use in cholecystectomy and colectomy. However, the agency said that the approved labeling for Exparel does not provide instructions for, or indicate that Exparel will be safe and effective for postsurgical pain, if used in surgical procedures other than hemorrhoidectomy or bunionectomy.

The FDA said that information required to demonstrate that Exparel is safe and effective for the new intended uses has not been submitted to it in an application.

According to the FDA, "These violations are extremely concerning from a public health perspective because they provide evidence of the intended use of Exparel in surgical procedures other than those for which the drug has shown to be safe and effective and they suggest that Exparel is more effective than has been demonstrated."

Further, the FDA noted that a journal ad by Pacira Pharma claimed Exparel as being able to provide pain-relief for up to 72 hours, while the drug is only approved for pain-relief up to 24 hours. The agency said these claims overstate Exparel's efficacy and are misleading.

The regulatory agency has asked Pacira to submit a written response to its warning letter by October 6, 2014. Noting that the violations are serious, the agency asked Pacira Pharma to include a comprehensive plan of action to "disseminate truthful, non-misleading and complete corrective messages" about the issues.

In response, Dave Stack, president, chief executive officer and chairman of Pacira Pharma said, "We take regulatory compliance very seriously and believe that our current labeling supports the claims being challenged by the FDA. We plan to explain our position to the FDA and will provide an update upon resolution of these issues."

PCRX is trading at $101.91, down $4.37 or 4.11 percent on a volume of 929,626 shares.