Pacira Pharma skids as FDA refuses to grant new clearance for post-surgery pain drug Exparel

Markets Associated Press

Shares of Pacira Pharmaceuticals tumbled Monday after the company said regulators refused to grant a new marketing approval for its post-surgical pain drug Exparel.

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Exparel is an injectable drug that is used to numb post-surgical pain. Pacira Pharmaceuticals wants to market the drug for blocking nerves to relieve pain after surgery, but the Food and Drug Administration did not give it marketing approval.

Exparel brought in $189 million in revenue for Pacira last year — 95 percent of the company's total sales. Last week Pacira had forecast $310 million to $330 million in revenue from Exparel in 2015, with 10 percent of that from sales of Exparel as a nerve-blocking agent.

The Parsippany, New Jersey, company said it plans to meet with the FDA to discuss its decision. It did not mention any changes to its guidance in a Monday statement.

Exparel is a long-acting drug that is designed to treat pain after surgery, and it does not contain opioids. Opioid medications are used to treat pain but they are often abused. Concerns about their addictive qualities has led to a push for new types of pain treatments.

In September the FDA warned Pacira Pharmaceuticals for its marketing practices. It said the company was asserting that Exparel worked for up to three days when it has only been approved for 24-hour pain relief.

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Pacira Pharmaceuticals Inc. shares fell $22.47, or 20 percent, to $92.30 Monday. Before that the stock had risen 29 percent in 2015 and it set an all-time high of $121.95 on Wednesday.