![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » DURECT ANNOUNCES START OF ITS PHASE II STUDY
DURECT ANNOUNCES START OF ITS PHASE II STUDY
July 12, 2005
Durect announced the start of dosing in the third and final cohort of the Phase II dose escalation study in hernia patients in Australia for Durect's postoperative pain relief depot, Saber-Bupivacaine.
The company anticipates approximately 60 patients will be enrolled in Cohort 3. Saber-Bupivacaine is based on Durect's patented Saber delivery technology and is intended to be administered around the surgical site after surgery to provide three days or more of regional pain relief.
The Phase II study is a dose escalation trial designed for dose optimization of the product candidate. It includes three cohorts for the treatment of pain in patients following repair of inguinal hernia. Six patients were enrolled in Cohort 1, and 15 patients were enrolled in Cohort 2. The following will be evaluated in the study: safety, pharmacokinetics, time to first supplemental analgesic, total supplemental analgesic usage, pain intensity and pain relief.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct