Results from the phase 3b ALPINE study, which evaluated Aristada (aripiprazole lauroxil; Alkermes) and Invega Sustenna (paliperidone palmitate; Janssen) in patients experiencing an acute exacerbation of schizophrenia, showed that both of these long-acting injectable treatments effectively controlled schizophrenia symptoms throughout the 6-month trial.
In ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), patients (N=200) were randomized to receive either Aristada (Aristada Initio regimen + Aristada every 2 months) or Invega Sustenna (loading dose + maintenance doses every month) over a 6-month period which included a 2-week inpatient phase, followed by an outpatient phase.
Results of the study showed a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total scores at Week 4 for both Aristada (-17.4 points; P<.001) and Invega Sustenna (-20.1 points; P<.001) treatment groups (pre-specified primary endpoint). At weeks 9 and 25 (secondary endpoints), PANSS total scores continued to improve for both groups (Aristada: -19.8 points [week 9] and -23.3 points [week 25]; Invega Sustenna: -22.5 points [week 9] and -21.7 points [week 25]; all P<.001).
The most common adverse reactions reported in both groups were injection site pain (Aristada 17.2% vs Invega Sustenna 24.8%), weight gain (Aristada 9.1% vs Invega Sustenna 16.8%), and akathisia (Aristada 9.1% vs Invega Sustenna 10.9%); 56.6% and 42.6% of patients in the Aristada and Invega Sustenna groups completed the 6-month study, respectively.
“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,” said Craig Hopkinson, MD, Chief Medical Officer at Alkermes.
Aristada is an atypical antipsychotic indicated to treat schizophrenia. Aristada Initio (in combination with oral aripiprazole) is indicated for the initiation of Aristada when used to treat adults with schizophrenia; it may be used to initiate patients onto any dose of Aristada.
Invega Sustenna, an atypical antipsychotic, is approved for the treatment of schizophrenia, and for schizoaffective disorder as monotherapy or as an adjunct to mood stabilizers or antidepressants.
For more information visit Alkermes.com.