In its press release on October 5, the U.S. Food and Drug Administration has announced that it has approved Aristada (aripiprazole lauroxil) extended release injection for the treatment of adults suffering with schizophrenia.
"Long-acting medications to treat schizophrenia can improve the lives of patients," said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.
"Having a variety of treatment options and dosage forms available for patients with mental illness is important so that a treatment plan can be tailored to meet the patient's needs."
Schizophrenia is a brain disorder affecting about one percent of Americans. The symptoms are usually first seen in adults who are younger than 30 years of age. The typical symptoms of schizophrenia include being suspicious, withdrawn, hearing voices in the head and believing that other people are controlling their mind.
For patients suffering with schizophrenia, Aristada is administered to the patient every four to six weeks using an injection in the arm or buttocks.
Aristada is manufactured by Alkermes, Inc. of Waltham, Massachusetts. Following FDA approval, Alkermes is preparing to launch the drug immediately, Boston Business Journal reports.
"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," said Dr. Elliot Ehrich, chief medical officer of Alkermes, according to Boston Business Journal.
"We look forward to making aristada available to patients and healthcare providers as quickly as possible."
According to the company, data showed that patients who were administered multiple dose strengths of aristada had shown improvements in schizophrenia symptoms versus placebo.
