Durect left with nail-biting wait based on FDA panel's Posimir split

20 January 2020

A US Food and Drug Administration (FDA)advisory panel vote on whether to approve Durect Corporation’s (Nasdaq: DRRX) painkiller Posimir (bupivacaine) ended in a tie.

The vote, which came out at six votes for and six against, leaves the Californian company with a nerve-wracking wait to see whether the FDA will again reject its submission for the drug, after doing so in 2014, or if the agency will change its mind.

Concerns raised by the Anesthetic and Analgesic Drug Products Advisory Committee members over the drug, which is designed for post-operative pain relief, included questions over effectiveness and side effects.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK