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# Alkermes sNDA for Aristada New Dosing Interval
- URL: https://www.fdaweb.com/alkermes-snda-for-aristada-new-dosing-interval/
- Published: 2016-08-09T12:00:00.000Z
- Updated: 2026-09-14T21:23:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136459

Alkermes has filed a supplemental NDA for a two-month dosing interval for Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophrenia. FDA approved the drug last year as the first long-acting atypical antipsychotic with once-monthly and once-every-six-weeks dosing options, according to the company.

The sNDA is based on positive results from a recent randomized, open-label trial that assessed Aristada’s pharmacokinetics (PK), safety and tolerability when administered at the investigational two-month interval and at the FDA-approved dosing intervals of once monthly and once every six weeks. Results from the study showed that patients achieved therapeutically relevant plasma concentrations of aripiprazole with a PK profile that supports dosing once every two months, Alkermes says.