For people suffering from schizophrenia, a long-acting injectable (LAI) antipsychotic drug that cuts doses by half could soon arrive in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has in fact expressed a positive opinion and recommended the granting of marketing authorization in the European Union (EU) for aripiprazole in injectable formulation every two months, instead of once a month, for maintenance treatment in adult patients already stabilized on aripiprazole.
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In schizophrenia
Schizophrenia is a chronic, disabling and progressive mental illness, characterized by delusions, hallucinations and cognitive disturbances, which can occur at variable intervals between periods of relative stability, and is among the 15 major causes of disability worldwide. Globally it affects around 24 million people (1 in 300): onset is more frequent in late adolescence and around the age of twenty, and onset tends to be earlier in men than in women. Schizophrenia is often associated with significant distress and impairment in personal, family, social, educational, occupational, and other important aspects 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 of aripiprazole in a pre-filled single chamber syringe) depends on the general poor adherence to antipsychotic treatment by patients. Poor adherence which, as numerous studies show, is related to relapses. The LAI formulation instead allows continuous exposure to the drug: thanks to a simplified treatment regimen, it can lead to improving this aspect and, consequently, reducing relapse rates compared to oral drugs.
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The antipsychotic drug
Aripiprazole is a partial agonist for dopamine D2 receptors developed by Otsuka and co-developed under a collaboration and licensing agreement between Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S. It is currently available in oral tablets, orodispersible tablets and oral solution, or in a LAI formulation with administration once a month, and in a fast-acting intramuscular injectable solution.
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The CHMP’s positive opinion on the new formulation is based on safety and efficacy data emerging from a 32-week pharmacokinetic bridging study: aripiprazole LAI once every two months has been shown to provide similar plasma concentrations, and therefore similar efficacy, as well as a safety and tolerability profile similar to that of aripiprazole LAI once monthly in 266 adults, of which 185 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 offers flexibility,” said Johan Luthman, Executive Vice President and Director of Research & Development at Lundbeck – Results from the once-every-two-month formulation study strengthen the long-term efficacy and safety profile of aripiprazole injectable LAI administered once monthly.” The final decision for 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 will continue to work intensively to provide them and their caregivers with new options in areas of medical need not satisfied,” concluded Peter Gillberg, Vice President Medical Affairs of Otsuka Europe.
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