US-based biopharmaceutical company Durect has concluded patient enrolment in its Phase III PERSIST clinical trial of Posimir (Saber-Bupivacaine) for pain relief following surgery.
Posimir is an investigational, non-opioid, extended-release depot that employs the firm’s Saber technology to deliver bupivacaine to the surgical site continuously for a period of 72 hours.
The two-part Phase III trial will include a total of 388 patients scheduled to undergo cholecystectomy (gallbladder removal) surgery.
In the first part of the trial, 92 patients will be given either Posimir or placebo, while the second part will involve administration of the drug candidate or standard bupivacaine HCl to 296 patients.
The primary efficacy endpoint for the second part is on movement from 0-48 hours following surgery, while key secondary endpoints include decrease of pain on movement from 0-72 hours after surgery and 72-hour opioid use.
Durect president and CEO James Brown said: "The early completion of enrolment in PERSIST is an important milestone for our Posimir development programme.
"We look forward to completing patient follow-up visits during the third quarter and announcing top-line data in the fourth quarter of this year."
The firm entered a development and commercialisation agreement with Novartis’ subsidiary Sandoz last month.
Under the agreement, Durect will be responsible for the completion of the PERSIST trial following discussions with the US Food and Drug Administration (FDA).
Upon assessment in a clinical trial, including 50 patients who have undergone laparoscopic cholecystectomy, Posimir is reported to provide up to 25% decrease in pain intensity on movement for the first three days after surgery when compared to bupivacaine HCl.