Irish biopharmaceutical company Alkermes has reported positive top-line data from the Phase IIIb ALPINE clinical trial of Aristada (aripiprazole lauroxil) to treat patients suffering from schizophrenia.
The six-month trial compared the efficacy, safety, and tolerability of every two months regimen of Aristada with monthly administration of Janssen’s Invega Sustenna (paliperidone palmitate).
Results showed that the trial met its primary endpoint with both drugs causing statistically significant and clinically meaningful decrease in Positive and Negative Syndrome Scale (PANSS) total scores from baseline at week four.
The PANSS total scores, which continued to improve at weeks nine and 25, were similar in both treatment groups without any statistical difference.
Alkermes chief medical officer Craig Hopkinson said: “The ALPINE study showed that both Aristada, given every two months, and Invega Sustenna, given every month, demonstrated statistically significant improvements from baseline in schizophrenia symptoms, and that the efficacy was similar for both medicines throughout the six-month study.
“This research provides evidence that these two long-acting medicines, each with their own distinct safety and tolerability profile, may be clinically useful in helping to bridge the critical transition between inpatient and outpatient settings of care.”
Aristada is an atypical antipsychotic medication approved in four doses and three dosing durations for treating schizophrenia patients in the US.
The randomised, double-blind, multi-centre ALPINE trial evaluated the medication in a total of 200 patients with an acute exacerbation of schizophrenia.
During an initial two-week inpatient phase, participants were initiated with 675mg Aristada Initio plus 30mg aripiprazole dose or 234mg Invega Sustenna.
This was followed by a six-month outpatient phase, when patients took 1,064mg Aristada every two months or 156mg Invega Sustenna every month.
Around 56.6% of participants in the Aristada group and 42.6% of those in the Invega Sustenna arm completed the six-month study.
The most common adverse events observed during the trial were injection site pain, increase in weight and akathisia.