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

20 January 2020
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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.

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