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Alkermes Announces Positive Topline Results From ALPINE Study

Alkermes plc (ALKS) announced Tuesday positive topline results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a first-of-its-kind, six-month study evaluating the efficacy, safety and tolerability of ARISTADA (aripiprazole lauroxil) and INVEGA SUSTENNA (paliperidone palmitate) 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 (1064 mg) every two months. Patients randomized to the INVEGA SUSTENNA treatment group were initiated using a loading dose of INVEGA SUSTENNA (234 mg) followed by INVEGA SUSTENNA (156 mg) every month.

The data from the ALPINE study provides clinical evidence of efficacy, safety and tolerability of ARISTADA INITIO and once-every-two-month ARISTADA dosing regimen, with favorable overall retention rate in study.

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 (PANSS), which is a standard psychiatric scale used for measuring symptom severity in schizophrenia.

The large, randomized ALPINE trial showed both long-acting injectable medications effectively controlled schizophrenia symptoms throughout six-month study. ARISTADA demonstrated significant and similar efficacy to current market-leader INVEGA SUSTENNA, with differences in safety and tolerability parameters.

Overall, 56.6% of patients in the ARISTADA treatment group and 42.6% of patients in the INVEGA SUSTENNA treatment group completed the six-month study.

Alkermes expects to submit results from the ALPINE study to peer-reviewed journals for publication and present full study results, including efficacy, safety, tolerability and exploratory analyses, at upcoming scientific meetings.

ALPINE was a multicenter, randomized, double-blind, phase 3b study evaluating the efficacy, safety and tolerability of ARISTADA and INVEGA SUSTENNA in 200 subjects experiencing an acute exacerbation of schizophrenia. The study included a two-week inpatient phase, during which all subjects were initiated onto either ARISTADA or INVEGA SUSTENNA, followed by an outpatient phase for a total of six months.

The study's pre-specified primary endpoint was the change from baseline in PANSS total scores at Week 4 within each treatment group.

The pre-specified secondary endpoints included the change from baseline in PANSS total scores at Week 9 and Week 25 within each treatment group, as well as between treatment group comparisons at Week 4, Week 9 and Week 25.

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