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12:00 AM
 | 
Dec 21, 2015
 |  BioCentury  |  Politics, Policy & Law

Relieving Pacira's pain

Why Pacira and FDA settled lawsuit over Exparel promotion

In September, when Pacira Pharmaceuticals Inc. asked a federal court to force FDA to lift restrictions on the company's promotion of Exparel bupivacaine, it looked like yet another drug company was launching a First Amendment challenge to the agency's enforcement practices. Based on the settlement filed with the court last week, it now looks like the controversy stemmed from a more prosaic cause: a management failure at FDA's Center for Drug Evaluation and Research.

The story starts in 2011, when CDER's Division of Anesthesia, Analgesia and Addiction Products (DAAAP) reviewed Pacira's NDA for Exparel, a liposomal extended-release version of bupivacaine, a generic analgesic.

Pacira submitted an NDA under the 505(b)(2) pathway seeking a broad indication for "postsurgical analgesia." Consistent with FDA's draft guidance on developing drugs for analgesic indications, the NDA included data from two Phase III trials that studied Exparel's use to control pain from hemorrhoidectomy and bunionectomy surgeries.

According to the guidance, to obtain "an indication of the treatment of general acute pain, two successful trials in nociceptive pain, one in visceral pain and one in nonvisceral pain, generally will be considered to be adequate."

However, the medical reviewer assigned to the application, Arthur Simone, argued against a broad indication because of differences in the dose and method of administration in the two trials. He agreed that Pacira had demonstrated safety and efficacy, but he recommended that Exparel's proposed indication be narrowed to postoperative analgesia following hemorrhoidectomy or bunionectomy.

Simone's superiors, including DAAAP Director Bob Rappaport, apparently disagreed.

The Exparel approval letter, dated Oct. 28, 2011, and signed by Rappaport, noted that the approved indication was "for single-dose infiltration into the surgical site to produce postsurgical analgesia." The indication was not limited to hemorrhoidectomy or bunionectomy procedures. The dosage and administration section of the label described its use in the two types of surgery that had been conducted in Phase III...

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