Trial Profile
A Placebo-controlled Trial (Part 1) or Active-controlled (Part 2) of SABER Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 14 Jul 2021
Price :
$35
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At a glance
- Drugs Bupivacaine (Primary) ; Bupivacaine
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Acronyms PERSIST
- Sponsors DURECT Corporation
- 11 May 2020 According to a DURECT Corporation media release, since the AADPAC meeting on January 16, 2020, the company continued to interact with the FDA as they continue their review of the POSIMIR NDA.
- 17 Jan 2020 According to a DURECT Corporation media release, the U.S. FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met yesterday to discuss the Class 2 NDA resubmission for POSIMIR. In a split vote on the key question, six advisory committee members voted to recommend that the efficacy, safety, and overall risk-benefit profile of POSIMIR support approval, while six did not support approval based on the information presented. A new user fee goal date has not been assigned.
- 02 Oct 2019 According to a DURECT Corporation media release, the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). The meeting is tentatively scheduled for January 16, 2020. The FDA had previously assigned a user fee goal date of December 27, 2019; a new user fee goal date has not been assigned.