Schizophrenia is a chronic, disabling brain disorder which ranks among the top 10 causes of disability in developed countries affecting approximately 1.1% of the population. The schizophrenia market is currently dominated by second generation (atypical) antipsychotics. These products have been very successful in eliminating or reducing the disease symptoms. However, treatment success during the maintenance phase is limited due to poor patient compliance. Furthermore, many atypicals still exhibit extrapyramidal symptoms (EPS) at high plasma levels.
Lack of Medication Adherence
Lack of medication adherence is one of the most frequently cited unmet needs in the treatment of schizophrenia. Patient medication adherence is estimated at only 30% – 70% of patients. Nonadherence is a major reason that neuroleptic drugs are not more effective in keeping people with schizophrenia out of the hospital and accounts for approximately 40% of all relapses. If medication is discontinued, the relapse rate is about 80% within 2 years (compared to 40% with continued drug treatment). With each successive relapse, the patient’s long-term prognosis deteriorates and previous level of functioning is rarely achieved.
The cost of Medication Non-Adherence
In addition to the impact of non-adherence to patients, one should also consider the impact on the healthcare system and society overall. Hospital costs from maintenance phase relapse in the United States due to medication noncompliance (i.e., excluding refractory patients) was estimated at over $700 Million per year in 1995. Furthermore, direct healthcare costs are not the only costs associated with relapse. The remaining costs include lost time from work, social services, criminal justice resources, etc. The overall U.S. 2002 cost of schizophrenia was estimated to be $62.7 billion, with $22.7 billion excess direct health care cost. Direct healthcare costs are estimated to be approximately 30% of the total schizophrenia cost, making the total cost of non-adherence over $2.3 Billion per year.
The Impact of Long Acting Formulations
Depot formulations have been introduced in the schizophrenia market and have illustrated the positive impact of long acting formulations in improving clinical outcomes. In 2003 the first atypical depot, Risperdal® Consta® (Consta), was introduced to the market. Consta, which is a 2 week injectable formulation of risperidone, showed very quickly the pharmacoeconomic benefits of a longer acting formulation by improving patient adherence.
The Limitations of Depot Formulations
Although depot formulations have demonstrated significant benefits, they display certain limitations including:
- Technical limit of depot technologies to provide consistent blood levels for more than a few weeks.
- Safety issues since the drug cannot be withdraw if needed.
- Cumbersome dosing schedule during treatment initiation (or re-initiation when a dose is missed).
- Long washout period which complicates the process of switching treatments.
- Poor pharmacokinetic profile resulting in side effects at high plasma levels.
The Future of Schizophrenia Treatment
Our goal is to develop once yearly therapies that overcome the limitations of depot technologies. We believe that such therapies will improve clinical outcomes and provide key differentiation. Delpor is currently developing products which will offer the following treatment benefits:
- 6-12 month system offering improved adherence to the medication
- Ability to withdraw the medication if needed (the implant device can be easily removed by any emergency room physician within 5-10 minutes)
- No oral supplements or a complex dosing schedule during treatment initiation or re-initiation (the system provides therapeutic levels of the drug immediately after implantation)
- No long washout periods at the end of treatment (drug plasma levels drop to zero within a day after explantation allowing an easy switch to another treatment if needed)
- Superior pharmacokinetic profile (no peaks and troughs resulting in enhanced safety and efficacy)
- Reduced invasiveness compared to depot formulations (one procedure replaces several painful injections)
- Reduced cost (fewer relapses and doctor visits)