ELADUR® (TRANSDUR®-Bupivacaine)

Overview

ELADUR is an investigational long-acting transdermal patch designed to deliver the local anesthetic bupivacaine to targeted areas of skin. Based on DURECT’s proprietary TRANSDUR technology, ELADUR is being studied for its ability to treat pain associated with post-herpetic neuralgia (PHN) for up to 3 days after a single application.

ELADUR is being studied for its ability to:

  • Provide a longer duration of pain control (3 days versus 12 hours) and fewer incidents of breakthrough pain than existing lidocaine patches for PHN
  • Use thinner and lighter weight materials, which could reduce skin irritation and improve wearability
  • Make use of a next generation adhesive for sweat and water resistance

Post-herpetic neuralgia (PHN) is a term that describes persistent neuropathic pain following an outbreak of shingles, a later-in-life complication of childhood chicken pox. Shingles typically occurs as a localized painful rash years after an initial infection with the varicella zoster (chicken pox) virus. In about 5%-30% of cases, depending on age and immune status, the pain fails to subside with resolution of the rash, and may become long-lasting, severe, and debilitating.

The prevalence of PHN (clinically significant pain lasting more than 3 months) has been estimated at approximately 144,000 people in the U.S. The pain associated with PHN can be difficult to treat with systemic drugs, but because it affects sensory nerves projecting to discrete areas of skin, it has be addressed with topically-applied anesthetic agents such as lidocaine. Worldwide sales of branded and generic lidocaine patches totaled $1.5 billion in 2014.

ELADUR is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.

ELADUR is a Phase 2 program under the direction of our licensee Impax Laboratories. ELADUR is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.

In January 2014, DURECT licensed the worldwide rights to develop and commercialize ELADUR to Impax Laboratories, Inc. For a description of the associated terms, please see Collaborations

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Learn more about TRANSDUR transdermal systems

There are risks and uncertainties associated with our business. Please see our most recent SEC filings (10-K or 10-Q) for a complete description of these risks and uncertainties, which are incorporated herein by reference.