A Multicenter Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less Than 17 Years
Phase of Trial: Phase III
Latest Information Update: 11 Oct 2019
Price : $35 *
At a glance
- Drugs Bupivacaine (Primary)
- Indications Postoperative pain
- Focus Pharmacokinetics; Registrational
- Acronyms PLAY
- Sponsors Pacira BioSciences
- 04 Oct 2019 Status changed from active, no longer recruiting to completed.
- 17 Sep 2019 According to a Pacira BioSciences media release, the company is intended use the results of this study as a foundation of a supplemental New Drug Application (sNDA) submission to the U.S. Food and Drug Administration (FDA) seeking expansion of the EXPAREL label to include children aged six and over.
- 17 Sep 2019 According to a Pacira BioSciences media release, the company has reached the full enrollment in this study.