DURECT INITIATES PHASE II TRIAL OF TRANSDERMAL BUPIVACAINE

Durect has begun dosing in a Phase II trial of Transdur-Bupivacaine (DUR-843), a transdermal pain patch for patients suffering from post-herpetic neuralgia (PHN).

Durect's Phase I trial of Transdur-Bupivacaine, reported in December, demonstrated good safety, tolerability and drug release for up to three days. Transdur-Bupivacaine is intended to provide up to three days of pain relief for patients suffering from PHN, as compared with a wearing time limited to 12 hours with currently available patches.

The Phase II program for Transdur-Bupivacaine has begun with a randomized, multicenter, double-blind, placebo-controlled, two-way-crossover trial in approximately 50 patients with PHN to assess safety as well as the magnitude, duration and characteristics of the analgesic activity of Transdur-Bupivacaine.

Bupivacaine, the active agent in Transdur-Bupivacaine, is a potent, FDA-approved, long-acting local anesthetic used in regional anesthesia including infiltration, nerve blocking, and epidural and intrathecal anesthesia. Bupivacaine is a more potent sodium channel blocker and has a longer duration of action than lidocaine, the active ingredient in Lidoderm, the market leader for post-herpetic neuralgia pain management, according to Durect.