Durect Corporation (NASDAQ: DRRX) lost ground in yesterday’s trading session, to close the day lower by 15.94%. This downside trend has sustained since the company announced that, the FDA advisory committee had arrived at a split decision with regards to its new treatment called POSIMIR. The company stated that, 6 of the FDA committee members voted in support of approval of POSIMAR on the basis of its efficacy, risk-benefit profile, and safety. On the other hand, 6 of them, did not approve the key question presented to them.
Commenting on the development, CEO James E. Brown stated that, they were glad to have got the opportunity to give presentation data on POSIMIR, and have a discussion with the FDA. He added that, the company was happy with the support that it received from the committee members. He also added that, the company still believes that the data it presented met the regulatory requirements, and that weight of the evidence that it provided was in favor of approval.
He concluded by stating that, the company was looking forward to working with the FDA as it continues to review the POSIMIR application. It is also noteworthy that, recommendations of the panel are not binding. However, the FDA puts its decisions into consideration when making regulatory decisions.
POSIMIR is Durect’s investigational treatment for post-operative pain relief. It makes use of the company’s patented technology called SABER. By its design, the treatment is put directly on the surgical site, and delivers bupivacaine for 72 hours after doctors complete a surgery.
Looking at its price action, DRRX is in a downtrend. In yesterday’s session, it opened the day at $2.39 and traded between $2.05 and $2.49 before closing at $2.11. Volumes in the day stood at 2.76 million.
About Durect Corporation
Durect Corporation is a biopharma company that develops treatments using an epigenetic regulator. It is based in Cupertino, California.