Alkermes submits sNDA for new dosage of Aristada for schizophrenia

Alkermes recently announced the submission of a supplemental New Drug Application to the FDA for a 2-month dosing interval of Aristada extended-release injectable suspension for schizophrenia.

Aristada (aripiprazole lauroxil, Alkermes) was approved by the FDA in October 2015 as a long-acting atypical antipsychotic with dosages once monthly and once every 6 weeks.

The supplemental New Drug Application (sNDA) draws on findings from a randomized, open-label trial among 140 individuals with stable schizophrenia.

Study participants received 441 mg of aripiprazole once per month, 882 mg every 6 weeks or 1,064 mg every 2 months.

Participants who received the 2-month dosage exhibited clinically relevant plasma concentrations of aripiprazole and a pharmacokinetic profile that supported dosing once every 2 months, according to a press release.

“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 health care providers require a range of options to meet their individualized needs,” Elliot Ehrich, MD, chief medical officer of Alkermes, said in the release. “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 2-month dosing option of Aristada to patients and physicians as quickly as possible.”