Ireland-based Alkermes is set to launch a Phase IIIb clinical trial of Aristada (aripiprazole lauroxil) extended-release injectable suspension to treat patients with acute exacerbation of schizophrenia.
Approved in four doses and three dosing durations, Aristada is an atypical antipsychotic that converts to aripiprazole inside the body.
The randomised, multi-centre, double-blind Phase IIIb trial will compare the safety and efficacy of Aristada with that of Invega Sustenna (paliperidone palmitate) in 180 patients.
Subjects will be administered with Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD), along with a single oral 30mg aripiprazole dose, followed by a two-month dose of Aristada, for a total of six months.
ALNCD is a new investigational product developed for initiation onto Aristada.
Alkermes research and development executive vice-president Elliot Ehrich said: “This study evaluating Aristada alongside Invega Sustenna, a medicine which is recognised in the medical community as a highly effective therapeutic option for schizophrenia, will provide helpful insight into the utility of these treatment options.
“The use of Aripiprazole Lauroxil NanoCrystal Dispersion to initiate onto two-month Aristada prior to hospital discharge represents an innovative approach to treating schizophrenia, and one we believe has the potential to significantly change the treatment paradigm.”
The trial’s primary efficacy endpoint changes in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week four in each treatment group.
Scheduled to start next month, the trial will monitor various secondary endpoints such as the change in PANSS total score between treatment groups at week four and its change from baseline at the end of the six months.