FDA approves Alkermes schizophrenia treatment
pharmafile | October 6, 2015 | News story | Research and Development | Alkermes, Aristada, FDA, schizophrenia
The US Food and Drug Administration (FDA) has approved Alkermes’s Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
Aristada is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaning therapeutic levels of medication in the body through an injection. Dublin, Ireland-based Alkermes says it is preparing to launch the treatment immediately.
An estimated 2.4 million American adults have schizophrenia, with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops the condition, which is considered one of the most serious types of mental illness.
Aristada features, including a range of dose strengths and dosing interval options, are designed to address the individual needs of patients and challenges in the treatment of schizophrenia. As a long-acting injectable medicine, ARISTADA provides patients, clinicians and families the certainty that patients receive medication for this serious brain disorder. Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time1 and help healthcare providers to track patient adherence.2
“Aristada is a new treatment option designed to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care,” says Elliot Ehrich, CMO of Alkermes.
“Building on nearly two decades of experience developing innovative medicines for chronic and serious CNS diseases, we are dedicated to helping to improve the lives of patients as well as meeting the needs within the treatment ecosystem of caregivers, physicians, payers and society. We look forward to making ARISTADA available to patients and healthcare providers as quickly as possible.”
“Schizophrenia is a serious and debilitating disease where, despite the existence of many medicines, there remains significant unmet medical need and suffering. New treatment options are needed to help patients and their families better manage this illness,” adds David Henderson, Associate Professor of Psychiatry at Massachusetts General Hospital. “Long-acting therapies are rapidly evolving to the forefront of the treatment of schizophrenia as clinicians increasingly recognise the potential benefits of less frequent dosing and consider their use earlier in disease progression.”
The FDA approval of Aristada was based on a proven safety and efficacy profile, including data from a randomised, double-blind, placebo-controlled, phase 3 study in 623 patients with schizophrenia.
Trial data showed that multiple dose strengths of Aristada met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12, met the key secondary endpoint and demonstrated significant improvements in schizophrenia symptoms versus placebo.
The most common adverse events in the study were insomnia, akathisia and headache. The results of the phase 3 study were published in June 2015 by The Journal of Clinical Psychiatry, a peer-reviewed medical journal.
Joel Levy
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