FDA Turns Down Pacira’s Request

Pacira Pharmaceuticals Inc. made a request to the U.S. Food and Drug Administration for an authorization to expand its use of a post-surgery pain drug. The increasing demand of the pain drug Exparel may have pressed them to get the approval which was only denied, sending down the company’s stock to more than 16 percent on Monday.

Exparel is used patients by injecting it directly into the tissue during a surgery procedure. The method is known as infiltration. In March of last year, Pacira Pharmaceuticals had requested to expand its use of the pain drug as a nerve-numbing injection or nerve block.

Nerve blocks are effectively used by introducing a local anesthetic close to a nerve, permitting the drug to control pain in certain parts of the body, such as the upper arm, thigh or lower leg.

The FDA’s refusal to Pacira’s proposal could also mean a delay of approval for the nerve block indication could be at least a year, Corey Davis said, an analyst of Canaccord Genuity

Exparel was approved for its purpose in post-surgical pain in April 2012 and had produced 95 percent of Pacira’s almost $ 197.6 million in profit last year.

Pacira said that the main drug’s main function as an effective nerve block is still the company’s first revenue driver.

Furthermore, Pacira added that last week they have expected Exparel to increase its sales to $310-$330 million in 2015. 10 percent of the said profit is actually coming from the expanded use of the drug.

On Monday Patricia said that they would try to deal with the FDA to get its approval for the new indication so that Exparel will be used in other ways for post-operative patients.

Pacira’s stock was down 15 percent on Monday afternoon and was the biggest drag on the Nasdaq Biotechnology Index.

The FDA approval is crucial to the drug’s success. Without it, the drug company’s stock value may go down just what happened here.


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