Alkermes Announces Positive Topline Results From Clinical Study Of Two-Month Dosing Option Of ARISTADA® For Treatment Of Schizophrenia

Alkermes plc announced positive topline data from a randomized, open-label, pharmacokinetic (PK) study evaluating a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. 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 events for the two-month dosing interval were injection site pain and dyskinesia. Based on these results, Alkermes plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and . . .