FDA Approves Post-Surgical Pain Medication

(National Institutes of Health)

Pacira Pharmaceuticals Inc. in Parsippany, New Jersey says the Food and Drug Administration has approved its drug Exparel for the management of post-surgical pain. The non-opioid local analgesic, says the company, can provide pain relief for surgical patients of up to 72 hours.

Exparel combines the compound bupivacaine in the company’s DepoFoam drug delivery platform. DepoFoam uses liposomes — lipid membrane bubbles — to deliver the drugs without disturbing the molecular composition of the drugs in the bubbles. The company says clinicians can use Exparel as they would other local anesthetics, but for longer periods of time.

Pacira says Exparel’s safety has been evaluated in 21 clinical trials, with more than 1,300 patients. The drug was also tested in 10 randomized double-blind clinical studies with 823 patients undergoing various surgical procedures, with doses ranging from 66 to 532 mg.

In these studies, the most common adverse reactions, documented in about 10 percent of patients, following Exparel administration were nausea, constipation, and vomiting.

Read more:

• FDA Approves Opioid Analgesic for Chronic Pain
• New Initiative to Speed Pain Treatments

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