Alkermes plc (NASDAQ: ALKS) reported Q4 EPS of ($0.15), $0.03 better than the analyst estimate of ($0.18). Revenue for the quarter came in at $163.1 million versus the consensus estimate of $162.21 million.

The company also 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 Drug Administration (FDA) in the second half of 2016.

“Schizophrenia is a complex disease that affects each patient differently, and healthcare providers need a variety of options to help address individual needs. These positive results support expanding the range of ARISTADA doses to include a once-every-two-month option,” stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “ARISTADA was designed from the outset to provide flexibility in terms of doses and dosing intervals. Based on these data, we look forward to working with the FDA to offer this important, new dosing option to patients and physicians as quickly as possible.”

The phase 1 study was a randomized, open-label trial that assessed the pharmacokinetics, safety and tolerability of ARISTADA when administered at the investigational two-month interval, as well as 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, for a total of eight months. Alkermes will present safety and PK data from the phase 1 study at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal.

ARISTADA was approved by the FDA in October 2015 as the first long-acting atypical antipsychotic for the treatment of schizophrenia with both once-monthly and six-week dosing options.

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