The objective of the proposed study is to develop a subcutaneous implant of risperidone that provides consistent therapeutic blood levels of the drug for 6 months after a single administration. The device is implanted during a simple, 10-minute, in-office procedure with local anesthetic. The benefits of the product include improved medication adherence, fewer relapses, ability to withdraw the medication if needed due to treatment-emergent Adverse Events (AEs), simple dosing schedule without any initiation required, and a smooth pharmacokinetic (PK) profile for improved safety and efficacy. Atypical antipsychotics have been used for years with great results for the treatment of schizophrenia. However, the effectiveness of these agents in maintenance treatment is limited due to poor medication adherence, which accounts for ~40% of all relapses and re-hospitalizations. With each successive relapse, the patient's long-term prognosis deteriorates and previous level of functioning is rarely achieved. The overall U.S. 2013 schizophrenia cost was estimated at $155 billion, so non-adherence places a tremendous burden on the healthcare system. The clinical benefits of long-acting injectable (LAI) formulations have already been proven, and LAIs are associated with fewer relapses. However, most LAIs only last for a few weeks, with the longest acting risperidone LAI lasting only 1-month. Although a longer duration would provide additional benefit, two critical barriers have impeded such development: (1) Safety issues since the drug cannot be withdrawn after administration, and (2) technical limits of LAI technologies to provide consistent blood levels for more than a few weeks due to declining PK. Delpor?s implant technology is designed to address these problems and achieve therapeutic coverage for 6 months. Although some implant technologies already exist, none of them are suitable for the delivery of risperidone. Results of recent studies show that 86% of physicians and 50% of patients support the use of implants in this disease area. Delpor has received Phase I and Phase II SBIR support for this program, which initially targeted a 3-month system.
The aims of these programs have been successfully completed, including all milestones required for the launch of a first-in-man clinical trial. The company has recently successfully completed a Phase I clinical trial showing flat PK without any serious AEs. Furthermore, we have been able to extend the product duration from 3 to 6 months. The main objective of this Phase IIB application is to combine private and public funds in order to complete a pivotal PK Comparability study and a Summative Human Factors study as requested by the FDA for an NDA submission. We are also planning to adapt our existing cGMP manufacturing process for commercial production, so we can avoid any bridging studies after the completion of the pivotal trial. The completion of the pivotal study will bring the product closer to an NDA submission. Market approval is expected approximately 1-2 years after completion of the pivotal trial proposed here, after a follow-on safety study has also been completed.
Patient non-adherence in schizophrenia is estimated at 24%-74% of patients and accounts for approximately 40% of all relapses. Compared to existing schizophrenia treatment alternatives, the proposed product will reduce relapses during maintenance treatment, improve safety, and increase overall treatment success. The final outcome will be an improvement in patient lives, and a reduction in overall healthcare costs.