Exparel Approved for Postsurgical Anesthesia

New Drugs , News / September 27, 2016

Exparel 1.3% (bupivacaine liposome injectable suspension) is now approved by the FDA for administration into the surgical site to produce postsurgical analgesia.

Exparel is an innovative product that combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. By utilizing this technology, a single dose of Exparel delivers bupivacaine for an extended period of time, providing analgesia with reduced opioid requirements for up to 72 hours.

The inability to effectively manage postsurgical pain is a challenge anesthesiologists and surgeons face on a daily basis. Typically, the first 48 to 72 hours after surgery are the most difficult in terms of pain control. Hence, a product like Exparel, offering local non-opioid analgesia, represents a well needed advancement in the management of post-surgical pain by providing analgesia for several days with a single intraoperative infiltration.

The safety of Exparel has been evaluated in 21 clinical trials, including over 1300 subjects in the safety database. Exparel administered locally into the surgical site was evaluated in 10 randomized, double-blind clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 mg to 532 mg of Exparel. In these studies, the most common adverse reactions (incidence >10%) following Exparel administration were nausea, constipation, and vomiting. Exparel is contraindicated in obstetrical paracervical block anesthesia. Other formulations of bupivacaine should not be administered within 96 hours following administration of Exparel.

Exparel is manufactured by Pacira Pharmaceuticals, Inc.

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