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FDA Rejects DURECT's Posidur NDA; Stock Tumbles 28% - Quick Facts

Specialty pharmaceuticals company DURECT Corp. (DRRX) said Wednesday that the U.S. Food and Drug Administration has rejected the New Drug Application for Posidur, an investigational drug for administration into the surgical site to produce post-surgical analgesia.

The announcement had a deleterious impact on DURECT shares, which tanked 28 percent in after-hours trade on the Nasdaq.

The FDA has determined that Posidur (SABER-Bupivacaine) cannot be approved as the New Drug Application, or NDA, does not contain enough information to show that the drug is safe when used in the manner described in the proposed label. The FDA has indicated that additional clinical safety studies need to be conducted.

DURECT is evaluating the issues brought forth by the FDA and plans to have further discussions with the Agency.

"In the coming months, we intend to work with the FDA to gain more clarity on the next steps that would be required to address the issues cited in the Complete Response Letter," stated James Brown, CEO of DURECT.

DURECT stock closed Wednesday at $1.95, down $0.17 or 8.02%, on a volume of 2.85 million shares on the Nasdaq. In after hours, the stock dropped $0.56 or 28.72% at $1.39.

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