The Food and Drug Administration approved Pacira's supplemental new drug application to expand the use of its long-acting local anesthetic, Exparel, in children.
1. Pacira's bupivacaine liposome injectable suspension product is used in a variety of procedures, including orthopedic and spine surgeries.
2. The FDA approved Exparel for adults in 2011 and now will allow surgeons to use the product for pediatric patients ages 6 years and older.
3. Exparel is the first long-acting local anesthetic approved for pediatric use. The approval is based on a phase 3 study of Exparel in pediatric patients undergoing spine and cardiac procedures, which found no safety concerns.
4. More than 8 million patients have received Exparel for nonopioid pain control.