FDA OK’s Alkermes’s schizophrenia drug

The U.S. Food and Drug Administration (FDA) has approved Alkermes’s two-month Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.

Alkermes said in its press release that Aristada is now FDA-approved in four doses and three dosing duration options 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.”