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Alkermes plc announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
This potential new two-month offering would expand the range of ARISTADA dosing intervals to include a third option for patients with schizophrenia. ARISTADA was approved by the FDA in October 2015 as the first long-acting atypical antipsychotic with once-monthly and once-every-six-weeks dosing options.
Alkermes also announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 14/663,042 related to ARISTADA, with allowed claims that will cover methods of treatment for schizophrenia. Alkermes expects this patent to issue within the next few months and expire no earlier than March 2035. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application.
“We are designing ARISTADA to offer unprecedented flexibility in terms of doses and dosing intervals because, as long-acting injectable antipsychotics continue to grow in the marketplace, it becomes more evident that patients with schizophrenia and their healthcare providers require a range of options to meet their individualized needs,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes.
“This step toward expanding the ARISTADA product offering adds to Alkermes’ growing suite of products to address the real-world needs of patients with schizophrenia. We look forward to working with the FDA to offer this important, new two-month dosing option of ARISTADA to patients and physicians as quickly as possible.”
The sNDA for ARISTADA is based on the positive results from a recent randomized, open-label trial that assessed the pharmacokinetics (PK), safety and tolerability of ARISTADA when administered at the investigational two-month interval and at the FDA-approved dosing intervals of once monthly and once every six weeks.
A total of 140 patients with stable schizophrenia were randomized to receive either 441 mg ARISTADA once per month, 882 mg ARISTADA every six weeks or 1064 mg ARISTADA every two months.
Results from the study showed that the 1064 mg dose of ARISTADA achieved therapeutically relevant plasma concentrations of aripiprazole with a PK profile that supports dosing once every two months. The most common adverse event for the two-month dosing interval was injection site pain.
