Alkermes says ALPINE study met pre-specified primary endpoint

Alkermes announced positive results from ALPINE, a first-of-its-kind, six-month study evaluating the efficacy, safety and tolerability of ARISTADA and INVEGA SUSTENNA when used to initiate patients experiencing an acute exacerbation of schizophrenia in the hospital and maintain treatment in an outpatient setting. Patients randomized to the ARISTADA treatment group were initiated using the ARISTADA INITIO regimen followed by ARISTADA every two months. Patients randomized to the INVEGA SUSTENNA treatment group were initiated using a loading dose of INVEGA SUSTENNA followed by INVEGA SUSTENNA every month. The ALPINE study met its pre-specified primary endpoint, demonstrating that both ARISTADA and INVEGA SUSTENNA had statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale total scores from baseline at Week 4. Additionally, PANSS total scores continued to improve at Week 9 and Week 25, the study’s pre-specified secondary endpoints. Improvements in PANSS total scores from baseline were similar and not statistically different between treatment groups at any assessment time point during the study.

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