Successful two months dosing study of Aristada (aripiprazole lauroxil) extended release for schizophrenia- Alkermes

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 FDA in the second half of 2016. 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 Aristadaevery 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.

Comment: This study will help differentiate Aristada from other long acting schizophrenia drugs, such as Abilify Maintenna, Invega Sustenna and Risperdal Consta and hopefully contribute to improvements in patient adherence.