Our ORADUR technology is a sustained release oral gel-cap containing the drug in the SABER matrix to deliver over a 12 to 24 hour period. The ORADUR gel-cap may also be resistant to drug abuse (e.g., by crushing or alcohol or water extraction) as compared to other controlled release dosage forms on the market today. ORADUR-based products can be manufactured by a simple capsule filling process by conventional methods making them readily scalable. These properties have the potential to make ORADUR-based products an attractive option for pharmaceutical companies that seek to develop abuse resistant sustained release oral products.

Our ORADUR Technology is the basis of Remoxy, a novel long-acting oral formulation of the opioid oxycodone, and is targeted to decrease the potential for oxycodone abuse. Remoxy is a twice daily controlled release formulation that is intended to match the performance of Oxycontin®, but with enhanced abuse deterrence properties. Remoxy is developed under a joint development and commercialization agreement between DURECT and Pain Therapeutics, Inc. The product is currently under Phase III clinical testing by Pain Therapeutics, Inc.

Worldwide sales of Oxycontin, the leading sustained release formulation of oxycodone, exceeded $2 billion in 2004. Diversion and misuse are a significant issue in the sale and distribution of strong opioids such as oxycodone. Abusers can easily extract the full dose from currently marketed time-release opioid preparations and administer the dose as a bolus (e.g. resulting in an immediate and large spike in opioid blood levels). This provides abusers with a fast and powerful morphine-like high. We believe that the ORADUR technology offers a significant advantage over other controlled release technologies as it is more difficult to misuse.