U.S. submission for Durect's Posidur is in the works

Durect ($DRRX) has announced its plans to submit an NDA for Posidur, its injectable long-acting formulation of bupivacaine being developed for the treatment of post-surgical pain. The product uses Durect's Saber biodegradable, controlled-release technology, which leaves a depot that can release drug for one day to three months.

Posidur has had some setbacks--Durect's shares dropped 30% when Phase III studies failed to show a significant improvement in pain versus placebo in patients undergoing abdominal surgeries. And in a Phase IIb trial in women who had hysterectomies, it showed equivalent activity to another injectable, but did not reduce patients' use of rescue opioids. In January, Takeda Pharmaceutical ($TKPHF) returned its European product rights to Posidur.

But Durect remains upbeat, and its shares seem to be stable. According to James Brown, president and CEO: "Based on our recent pre-NDA communications with the FDA, we intend to submit a new drug application for Posidur in late 2012 or early 2013." He added: "We believe that Posidur may offer benefit to patients by providing local analgesia for up to three days after surgery."

In a roundup of its programs after the announcement of its second quarter 2012 financial results, Durect mentioned that it is in discussions with potential partners regarding licensing development and commercialization rights over two transdermal products, Transdur-sufentanil for chronic pain and Eladur (Transdur-bupivacaine) for neuropathic conditions including post-herpetic neuralgia. Both of these are in Phase II. Durect is also in partnering discussions for Posidur and Oradur-ADHD (a sustained release oral gel-cap of an undisclosed drug in Phase I).

- read the press release about the NDA
- see the press release on the financial results