Aristada, the new drug for treating schizophrenia, received the regulatory approval of the FDA on Monday. Alkermes PLC, which manufactured the drug, stated that it is prepared to be launched it to the market immediately.
“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,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes.
The drug is the first antipsychotic offering healthy therapeutic levels of medications to the patient’s body, providing an alternative to the oral antipsychotic medicines taken on daily bases. It comes in the form of an injection, having a long-acting effect, and it could be taken once in a month or every six weeks. On its final-stage trial, Aristada helped to reduce the patient’s symptoms.
The drug is expected to address to the individual needs of every patient. With their treatment method, they are looking to assure families and doctors that the patient is constantly receiving the medicine they need.
According to the press release, “Long-acting injectable antipsychotics 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.”
The FDA made the approval based on studies that proved the safety and efficacy of the drug, analyzing data from several studies conducted on 623 patients with schizophrenia, demonstrating its effectiveness. However, adverse events like insomnia, akathisia and headaches were reported. The results of the studies can be read at The Journal of Clinical Psychiatry.
“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,” Ehrich added.
According to information from the National Institute of Mental Health, schizophrenia is a chronic, disabling brain disorder that affects about 1% of the U.S. population.
Alkermes also announced that they will keep focusing on central nervous system diseases, developing another schizophrenia drug, treatments for multiple sclerosis and major depressive disorder, according to Bloomberg.
“We look forward to making Aristada available to patients and healthcare providers as quickly as possible,” Ehrich concluded.
Source: Business Wire