Pacira BioSciences Inc. plans to file for expanded approval of Exparel in the U.S. in 2020 after the non-opioid pain drug met the main goal of a late-stage study in children undergoing spinal or cardiac surgeries.
The phase 3 trial, dubbed Play, enrolled 98 patients who were divided into two groups. The first group consisted of patients aged 12 to less than 17 years while the second group consisted of children aged 6 to less than 12 years.
The Parsippany, N.J.-based pharmaceutical company said results from the study were consistent with the pharmacokinetic — study of the time course of drug absorption and metabolism — and safety profiles of Exparel as previously seen studies in adult patients.
Exparel is approved in the U.S. as a single-dose infiltration in adults for administration into the site of surgery for post-surgery pain relief and as a nerve block — a form of regional anesthesia injected into nerves before surgery — for regional pain relief. The company is also seeking EU approval of the drug.
Pacira said in a Dec. 17 press release that no safety concerns were seen in the patients at the 4 milligrams/kilogram dosage of the drug.
Pacira said that as per the U.S. Food and Drug Administration's guidance, the main objectives of the trial were to evaluate the pharmacokinetics and safety of the medicine in children.
The company noted that the results will help in filing a supplemental new drug application with the FDA in the first half of 2020.
Pacira noted that it expects to begin a second phase 3 registration study of Exparel, administered as a nerve block in children, in 2020.