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DURECT Corporation Announces First Quarter 2013 Financial Results and Update of Programs
Date:5/2/2013

ing development and commercialization rights to these two transdermal programs for which we hold worldwide rights.
  • ORADUR-ADHD Program.  We are developing a drug candidate (ORADUR-ADHD) based on DURECT's ORADUR Technology for the treatment of Attention Deficit Hyperactivity Disorder. This drug candidate is intended to provide once-a-day dosing with added tamper-resistant characteristics to address common methods of abuse and misuse of these types of drugs.  We and Orient Pharma have completed several Phase I pharmacokinetic studies with multiple formulations, and we are continuing to optimize our lead formulations.  Orient Pharma is our licensee for certain Asian and South Pacific countries, while we retain the rights to the rest of the world.
  • Relday (Risperidone Program).  In January 2013, Zogenix (our licensee) announced positive single-dose pharmacokinetic (PK) results from a Phase 1 clinical trial of Relday.  According to Zogenix, adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products. The Phase 1 clinical trial for Relday was conducted as a single-center, open-label, safety and PK trial of 30 patients with chronic, stable schizophrenia or schizoaffective disorder.  Per Zogenix, based on the favorable safety and PK profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial, Zogenix extended the study to include a 100 mg dose of the same formulation. In May 2013, Zogenix announced positive results with the 100 mg arm, demonstrating dose proportionality across the full dose range that would be anticipated to be used in clinical practice.
    Relday is a proprietary, long-acting, once-monthly subcutaneous injectable formulation of risperidone using DURECT's SABER controlled-release formulation technology.  An existing long-acting injectable r
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