For people suffering from schizophrenia, a long-acting injectable (LAI) antipsychotic that halves the dose may soon come onto the market in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has actually expressed a positive opinion and recommended that a marketing authorization for aripiprazole in injectable formulation in the European Union (EU) be granted every two months instead of once a month for maintenance therapy in adults Patients already stabilized on aripiprazole.
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Schizophrenia is a chronic, disabling and progressive mental illness characterized by delusions, hallucinations and cognitive disturbances that can occur at varying intervals between periods of relative stability and is one of the 15 leading causes of disability worldwide. It affects around 24 million people (1 in 300) worldwide. The condition is more common in late adolescence and around age 20, and males tend to develop the condition earlier than females. Schizophrenia is often associated with significant distress and impairment in personal, family, social, academic, professional, and other important areas of life.
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The problem of adherence and the risk of relapse
The need for a new formulation with a longer duration of action (960 mg aripiprazole in a prefilled single-chamber syringe) depends on the generally poor adherence of patients to antipsychotic treatment. Poor adherence, which numerous studies show is linked to relapse. The LAI formulation instead allows continuous exposure to the drug: thanks to a simplified treatment regimen, it can lead to an improvement in this aspect and therefore a reduction in relapse rates compared to oral medications.
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Aripiprazole is a dopamine D2 receptor partial agonist developed by Otsuka and licensed under a collaboration and licensing agreement between Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S was developed jointly. It is currently available in oral tablets, orodispersible tablets and oral solutions or in a once-monthly LAI formulation and in a rapid-acting intramuscular injectable solution.
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The CHMP’s positive opinion on the new formulation is based on safety and efficacy data from a 32-week bridging pharmacokinetic study: aripiprazole LAI once every two months has been shown to provide similar plasma concentrations and therefore similar efficacy and a safety and tolerability profile similar to that of aripiprazole LAI once monthly at 266 adults, 185 of whom were diagnosed with schizophrenia. “This is an important milestone in our efforts to offer adult patients with schizophrenia a new option that supports treatment goals and provides flexibility,” said Johan Luthman, executive vice president and director of research and development at Lundbeck – results of the single-occurrence study. The two-month formulation study strengthens the long-term efficacy and safety profile of the once-monthly injectable aripiprazole LAI.” The final decision on the approval of the drug by the European Commission is expected in the coming months: “New treatment options are needed for patients with schizophrenia and we “We will continue to work hard to provide them and their caregivers with new opportunities in medical fields.” This need is not being met,” concluded Peter Gillberg, Vice President of Medical Affairs at Otsuka Europe.