Durect Corp. (NASDAQ: DRRX) shares dropped early on Friday after the U.S. Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) announced its vote on Posimir, the company’s pain relief treatment. Ultimately, the vote did not go as Durect investors hoped. However, this FDA move was similar to an AADPAC vote we saw earlier this week for Nektar Therapeutics,
The FDA’s AADPAC met Thursday to discuss the Class 2 New Drug Application (NDA) resubmission for Posimir (bupivacaine extended-release solution). In a split vote on the key question, six advisory committee members voted to recommend that the efficacy, safety and overall risk-benefit profile of Posimir support approval, while six did not support approval, based on the information presented.
Although the FDA considers the recommendations of the AADPAC, the recommendations by the panel are non-binding. The final decision regarding pending regulatory actions for a product is made by the FDA.
James E. Brown, president and CEO of Durect, commented:
We appreciated this opportunity to present an in depth overview of our Posimir data and discuss it with the committee. We are encouraged by the support from a number of the Committee members. We continue to believe the data meets all of the regulatory requirements and that the weight of the evidence supports approval. We look forward to working with the agency as it completes its review of the POSIMIR application.
Some background: Posimir is the company’s investigational post-operative pain relief depot product that utilizes Durect’s patented Saber technology. Posimir is designed to be administered directly into the surgical site to deliver bupivacaine for up to three days after surgery.
Durect stock traded down more than 11% early Thursday at $2.25 a share, in a 52-week range of $0.50 to $3.95. The consensus price target is $4.20.
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