WASHINGTON (AP) — Shares of Pacira Pharmaceuticals jumped nearly 15 percent Tuesday after federal health regulators dropped a longstanding objection to marketing of a post-surgical pain drug.
The company's injectable drug, Exparel, was drug approved in 2011 for use in numbing pain after surgery. But in 2014, the Food and Drug Administration issued a warning letter to Pacira over promotions for the drug, saying the drug had only been shown effective after bunion and hemorrhoid surgeries.
The Parsippany, New Jersey company objected to that interpretation and filed a lawsuit against the FDA in September.
On Tuesday, the FDA posted a letter clarifying that Exparel could indeed be used in a variety of surgeries, noting that it had rescinded the warning letter from 2014.
"FDA determined that the indication approved in 2011, was not limited to bunionectomy and hemorrhoidectomy procedures," states Dr. Janet Woodcock, the FDA's top drug regulator, in a letter posted online.
Pacira said in a statement that it has resolved its lawsuit against the government, in light of the FDA's actions.
The case appears to be another victory for the drug industry over the issue drug marketing. In August, a federal judge sided with drugmaker Amarin in a similar lawsuit against the FDA, saying the company had a First Amendment right to give doctors truthful information about alternative uses of its fat-lowering drug.
Pacira's drug, Exparel, is a long-acting drug that is designed to treat pain after surgery, and it does not contain opioids. Opioid medications are the most-widely prescribed drugs for pain, but they are frequently abused. Concerns about their safety have led to a push for new types of pain treatments.
Pacira Pharmaceuticals Inc. shares rose $8.14, or 13 percent, to $70.57.