Background Analysis: US FDA Advisory Committee to Review POSIMIR, a Post-Surgical Analgesia Proposed by DURECT – JAN 16, 2020 (AADPAC)

Announcement

The US FDA has scheduled a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) for Thursday, January 16, 2020. The committee will discuss a new drug application (NDA) resubmission for bupivacaine extended-release solution for instillation (Proposed US trade name: POSIMIR), submitted by DURECT Corp. (Durect), for the proposed indication of post-surgical analgesia.

The committee will discuss whether the Durect adequately demonstrated the safety and efficacy of POSIMIR for post-surgical analgesia and the appropriateness of the proposed patient populations. The committee will also be asked to discuss the approvability of this product.

Background

Product Description

POSIMIR is an investigational extended-release depot designed to continuously delivery bupivacaine to post-surgical sites for 72 hours to relieve pain and reduce opioid use.

Clinical Trials

In all, Durect says they have completed 16 clinical trials in the POSIMIR development program, involving over 1,400 patients, over 850 of whom received POSIMIR, with the remainder in control groups. Durect believes this is a sufficiently sized safety database. Among all of the clinical trials, effectiveness appears to be primarily based on two clinical trials, conducted in patients undergoing inguinal hernia repair (N = 124, ClinicalTrials.gov Identifier: NCT00974350) and subacromial decompression (shoulder) surgeries (N = 60, ClinicalTrials.gov Identifier: NCT00818363). Trial results have not yet been posted to ClinialTrials.Gov, but the site links to a publication of results for the hernia trial. This publication reports that the 5.0 mL dose of POSIMIR reduced the mean area under the curve of pain intensity on movement compared with placebo (2.47 versus 3.60; P = 0.0033) and decreased the number of patients requiring supplemental opioids by 26% (although not statistically significant; P = 0.0909), in patients who underwent hernia surgery.

A comprehensive summary of the data package in the NDA will be made available two days prior to the AADPAC meeting, in briefing materials posted online by the FDA. These materials will be summarized on the day they are posted, in our subsequent report, the Briefing Summary.

Regulatory History

US Regulatory History

December 27, 2019 – Prescription Drug User Fee Action (PDUFA) goal date

July 17, 2019 – Durect announced the FDA’s acceptance of the class 2 NDA resubmission (NDA 204803) for 6 month review.

Ex-US Regulatory History

Tarius did not find any reports in the public domain pertaining to ex-US development of oxycodegol.

What’s Next?

Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: Durect Drug Name: bupivacaine Drug Class: anesthetic Indication: post-surgical analgesia

For more information about SAC Tracker reports and other benefits for our subscribers, click here.

DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.