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# FDA Still Questions Durect’s Posimir
- URL: https://www.fdaweb.com/fda-still-questions-durects-posimir/
- Published: 2020-01-15T12:00:00.000Z
- Updated: 2026-09-14T15:58:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145856

The FDA Anesthetic and Analgesic Drug Products Advisory Committee will discuss 1/16 Durect Corp.’s 10/2019 response to a 2/12/14 FDA complete response letter for its Posimir (bupivacaine extended-release solution) with a proposed indication for administration into a surgical incision to produce post-surgical analgesia. The complete response letter raised neurological safety issues with the NDA. FDA medical reviewers still have neurological concerns that the committee will be asked to consider.

A [briefing document](https://www.fda.gov/media/134171/download?ref=fdaweb.com) distributed in advance of the advisory committee meeting says “there are a lot of data for consideration with this complete response resubmission. The efficacy of Posimir is based on the local effects of bupivacaine while the safety is based on both local effects (e.g., inflammation at the surgical site and extended duration of the polymer at the site of administration) and on systemic levels (e.g., risk of local anesthetic system toxicity and the release of benzyl alcohol from the formulation).”

Committee members will be asked to consider: 

- whether Durect has provided enough information to support the indication;
- whether there are issues with the Durect complete response resubmission that warrant additional studies and if so, whether such studies should be conducted before or after approval; and
- whether the efficacy, safety, and overall risk-benefit profile of Posimir support the approval of the application.