FDA Approves Two-Month Aristada for Treatment of Schizophrenia

Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. Aristada is now FDA-approved in four doses and three dosing duration options (441 mg, 662 mg or 882 mg once monthly, 882 mg once every six weeks and 1064 mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers. The new two-month dose is expected to be available in mid-June.

"We designed Aristada to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care. As the first and only long-acting atypical antipsychotic approved in three dosing durations and with the ability to initiate treatment at any dose or duration, Aristada provides a range of options to help clinicians tailor treatment to the individual needs of their patients," said Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. "Building on nearly two decades of experience developing innovative medicines for chronic and serious CNS diseases, we are dedicated to helping improve the lives of patients with treatment options that are well-suited for use in today’s complex treatment system."

Treatment adherence for patients on daily therapy for chronic diseases is a known challenge for patients, and schizophrenia may make this challenge even greater. Long-acting injectable medications, like Aristada, eliminate the burden of taking an oral antipsychotic medicine on a daily basis. The newly approved two-month Aristada gives people living with schizophrenia an option to treat their symptoms with only six injections per year.

"Transitioning patients with schizophrenia from inpatient care to outpatient settings can be challenging. The availability of an antipsychotic that can be initiated prior to hospital discharge and provide therapeutic levels of medication for two months will be a welcome new treatment option for healthcare providers, caregivers and patients," said Joseph McEvoy, M.D., I. Clark Case Distinguished Chair in Psychotic Disorders at Augusta University and Professor Emeritus of Psychiatry and Behavioral Health at Duke University Medical Center. "The clinical community is increasingly using long-acting atypical antipsychotic medications earlier in the treatment paradigm as recognition grows of the benefits of less frequent dosing and the resulting ability to focus on other important treatment goals for patients."

About Schizophrenia

Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million American adults have schizophrenia,¹ with men and women affected equally.

About Aristada

Aristada is an injectable atypical antipsychotic with one-month, six-week and two-month dosing options for the treatment of schizophrenia. Aristada is administered by a healthcare professional. Once in the body, Aristada converts to aripiprazole. Aristada was originally approved by the FDA in October 2015.

About Alkermes

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.