Bupivacaine, an investigational transdermal drug patch for low back pain, has been undergoing a phase IIb clinical trial, according to Durect Corporation.
Durect has started clinical studies to evaluate Eladur (Transdur-Bupivacaine) for the treatment of chronic low back pain.
Eladur transdermal drug patch is intended to deliver bupivacaine for up to 3 days from a single application.
This Phase IIb trial is a 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Eladur in patients with chronic low back pain. King expects to enroll approximately 260 patients in the study.
“We’re pleased that King is developing Eladur for chronic low back pain, a clinical indication for which currently marketed anesthetic patches are not approved,” stated James E. Brown, president and CEO of Durect Corporation.
If approved for chronic low back pain, bupivacaine patch has the potential to compete strongly in the large market for topical pain products given its patient friendly design and extended duration of therapeutic use, Mr Brown hoped.
Bupivacaine, the active agent in Eladur, is a potent, FDA-approved long-acting local anesthetic used in regional anesthesia for local tissue infiltration, nerve block, and epidural and intrathecal anesthesia.
Bupivacaine, which has been marketed in the brand name Eladur has been originally developed by Alpharma.
In October 2008, Durect signed a development and license agreement with Alpharma Ireland Limited (subsequently acquired by King Pharmaceuticals in December 2008) whereby Alpharma was granted the exclusive worldwide rights to develop and commercialize Eladur, an investigational bupivacaine patch.
Under the terms of the agreement, Alpharma paid DURECT an upfront license fee of $20 million, with possible additional payments of up to $93 million upon the achievement of predefined development and regulatory milestones spread over multiple clinical indications and geographical territories as well as possible additional payments of up to $150 million in sales-based milestones.
If Eladur is commercialized, Durect would also receive royalties on product sales. Alpharma controls and funds further development of the program.
Durect is an emerging specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including Remoxy, Posidur, Eladur, and Transdur-Sufentanil.
Durect’s proprietary oral, transdermal and injectable depot delivery technologies may enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs.