Ireland-based Alkermes has received approval from the US Food and Drug Administration (FDA) for Aristada (aripiprazole lauroxil) extended-release injectable suspension to treat schizophrenia.
Aristada features a range of dose strengths and dosing interval options, and will be launched by the company immediately.
It is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection.
As a long-acting injectable medicine, Aristada is designed to address the individual needs of patients and challenges in treating schizophrenia.
The drug provides patients, clinicians and families the certainty that patients receive medication for this serious brain disorder.
The long-acting injectable antipsychotics available in the product provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time and help healthcare providers to track patient adherence.
Alkermes chief medical officer Dr Elliot Ehrich said: "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.
"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."
The approval was based on the safety and efficacy profile, including data from a randomised, double-blind, placebo-controlled Phase III trial in 623 patients with schizophrenia.
The 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, and also met the key secondary endpoint and showed significant improvements in schizophrenia symptoms versus placebo.
Massachusetts General Hospital Psychiatry associate professor David Henderson said: "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.
"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 company noted that injection-site reactions were reported by 4%, 5%, and 2% of patients treated with 441mg Aristada, 882mg Aristada, and placebo respectively.
Image: Aristada has multiple options for dose strengths, dosing intervals and site for administering the intramuscular (IM) injection in a pre-filled syringe. Photo: courtesy of Business Wire.