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Durect announces positive clinical results with its Oradur sustained release oral gel-cap technology
Cupertino | Thursday, July 8, 2004, 08:00 Hrs  [IST]

Durect Corporation announced the advancement of its Oradur sustained release oral gel-cap technology (formerly referred to as the SABER oral gel-cap technology) with positive human clinical results for Remoxy. Remoxy is a novel long-acting oral formulation of oxycodone based on Durect's Oradur technology under development by Pain Therapeutics Inc, which is targeted to decrease the potential for drug misuse or abuse.

On June 29, 2004, Pain Therapeutics announced the results of studies conducted in human volunteers in the United Kingdom to confirm Remoxy's anti-abuse properties and to assess the drug's pharmacokinetics.

"We are very pleased with the progress that Pain Therapeutics has made thus far with the clinical study results for Remoxy. These results reinforce our belief that products developed with our Oradur sustained release oral gel-cap technology may offer a variety of benefits, including the potential to reduce abuse when compared to current long-acting dosage forms that are on the market today," stated James E. Brown, president and CEO of Durect. He added, "We look forward to working with a variety of pharmaceutical companies, including Pain Therapeutics, to develop more innovative sustained release oral gel-cap products using this exciting technology."

The results of the Remoxy clinical studies reported were attributed to the unique characteristics of the Oradur sustained released oral gel-cap technology. Products based on the Oradur technology can take the form of an easy to swallow gelatin capsule that uses a high-viscosity base component, such as sucrose acetate isobutyrate (SAIB), to provide controlled release of active ingredients for a period of from 12 to 24 hours of drug delivery.

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